<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03042702</url>
  </required_header>
  <id_info>
    <org_study_id>CTIX-KEV-201</org_study_id>
    <nct_id>NCT03042702</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer</brief_title>
  <official_title>A Phase 2 Study of Kevetrin (Thioureidobutyronitrile) in Subjects With Platinum-Resistant/Refractory Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovation Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovation Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an&#xD;
      anti-proliferative p53 activator pharmacological class, for the treatment of cancer.&#xD;
      Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild&#xD;
      type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.&#xD;
&#xD;
      In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be&#xD;
      evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to&#xD;
      evaluate the pharmacokinetics of Kevetrin when administered to subjects with&#xD;
      platinum-resistant/refractory ovarian cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, dose-escalation trial to study the safety, biomarker changes&#xD;
      (including modulation of p53), objective tumor response changes, and pharmacokinetics&#xD;
      following administration of two different treatment regimens of Kevetrin over a 3-week period&#xD;
      to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of&#xD;
      Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin&#xD;
      treatment. Standard of care treatment, as medically appropriate and per local guidelines,&#xD;
      outside of this study protocol can commence after the collection of the post-Kevetrin&#xD;
      treatment biomarker samples (collected on Day 21±1 day). The patient population recruited&#xD;
      into this study includes those ovarian cancer patients that have platinum&#xD;
      resistant/refractory disease, defined as disease progression/relapse within 6 months&#xD;
      following the last administered dose of platinum therapy (resistant), or lack of response or&#xD;
      disease progression while receiving the most recent platinum based therapy (refractory),&#xD;
      respectively. Patients may or may not have had additional treatment (e.g., Doxil) prior to&#xD;
      entry in this study.&#xD;
&#xD;
      A total of approximately 10 study participants are planned to be enrolled in two cohorts of&#xD;
      approximately 5 subjects per cohort, with enrollment in a sequential, dose-escalating&#xD;
      fashion. Investigators and subjects will be aware of the treatment cohort into which they are&#xD;
      recruiting. Cohort details and the planned doses are:&#xD;
&#xD;
      Cohort 1 (n=5) Kevetrin Cycle - Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3&#xD;
      doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for&#xD;
      3 weeks after Kevetrin treatment ends Cohort 2 (n=5) Kevetrin Cycle - Kevetrin 350 mg/m2 IV&#xD;
      per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks&#xD;
      (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohorts 1&#xD;
      and 2 will be conducted in a sequential fashion, with safety data from cohort 1 evaluated by&#xD;
      an independent Data Monitoring Committee (DMC). The DMC will make appropriate recommendations&#xD;
      based on the available safety data as regards the intent of progressing to the higher dose&#xD;
      cohort 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">November 10, 2017</completion_date>
  <primary_completion_date type="Actual">November 10, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Reporting of Adverse Events, and severity of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Changes in Biomarkers</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants by RECIST Tumor Response Category</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.&#xD;
CR (Complete Response): Disappearance of all target lesions PR (Partial Response) : At least a 30% decrease in the sum of the longest diameters of target lesions PD (Progressive Disease) : At least a 20% increase in the sum of the longest diameters of target lesions SD (Stable Disease) : Small changes that do not meet above criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5</measure>
    <time_frame>Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour</time_frame>
    <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5</measure>
    <time_frame>Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour</time_frame>
    <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5</measure>
    <time_frame>Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour</time_frame>
    <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Kevetrin 250 mg/m2 IV Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kevetrin 350 mg/m2 IV Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kevetrin 350 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kevetrin</intervention_name>
    <description>Kevetrin dose to associated cohort</description>
    <arm_group_label>Kevetrin 250 mg/m2 IV Cohort 1</arm_group_label>
    <other_name>Cohort</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kevetrin</intervention_name>
    <description>Kevetrin dose to associated cohort</description>
    <arm_group_label>Kevetrin 350 mg/m2 IV Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Evidence of a personally signed and dated written informed consent to participate in&#xD;
             the clinical study&#xD;
&#xD;
          2. Non-pregnant female adults at least 18 years of age at time of informed consent&#xD;
&#xD;
          3. Histologically confirmed serous epithelial ovarian cancer with peritoneal metastases&#xD;
&#xD;
          4. Platinum resistant/refractory disease, defined as disease progression/relapse within 6&#xD;
             months following the last administered dose of platinum therapy (resistant), or lack&#xD;
             of response or disease progression while receiving the most recent platinum based&#xD;
             therapy (refractory), respectively&#xD;
&#xD;
          5. Measurable disease, as determined by radiologist evaluator, with at least 1&#xD;
             unidimensional measurable lesion (target lesion) by RECIST v.1.1 that has not&#xD;
             previously been irradiated or biopsied&#xD;
&#xD;
          6. Presence of non-target lesions that have not previously been irradiated or biopsied;&#xD;
             to allow for collection of needle-biopsies at Screening and after completion of&#xD;
             Kevetrin treatment&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          8. Adequate hematologic and organ function as confirmed by laboratory values at&#xD;
             Screening:&#xD;
&#xD;
               1. Bone marrow function: Absolute neutrophil count (ANC) ≥ 1500 Cells/μL (with no&#xD;
                  evidence that this ANC was induced or supported by granulocyte colony stimulating&#xD;
                  factors)&#xD;
&#xD;
               2. Hemoglobin ≥ 9 g/dL (with no RBC transfusions within 7 days of Screening)&#xD;
&#xD;
               3. Platelets ≥ 100,000 cells/μL (with no evidence that this platelet count was&#xD;
                  induced or supported by a platelet-stimulating agent)&#xD;
&#xD;
               4. Renal function: creatinine ≤ 1.5 x ULN&#xD;
&#xD;
               5. Hepatic function: total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN; alkaline&#xD;
                  phosphatase ≤ 2.5 x ULN&#xD;
&#xD;
               6. Neurologic function: neuropathy (sensory and motor) ≤ CTCAE Grade 1&#xD;
&#xD;
               7. Coagulation status: prothrombin time (PT) ≤ 1.5 ULN or INR within normal limits;&#xD;
                  and partial thromboplastin time (PTT) ≤ 1.2 × ULN&#xD;
&#xD;
          9. Women of child-bearing potential are required to use effective contraception&#xD;
             throughout the study period. Effective contraception methods include:&#xD;
&#xD;
               1. Total abstinence (if this is the usual lifestyle of the subject). Periodic&#xD;
                  abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and&#xD;
                  withdrawal are not acceptable methods of contraception. (Subject must agree to&#xD;
                  use contraception should they become sexually active while on the study.)&#xD;
&#xD;
               2. Surgical sterilization (hysterectomy and/or bilateral oophorectomy) or tubal&#xD;
                  ligation at least six weeks before start of study treatment.&#xD;
&#xD;
               3. Male partner sterilization, occurring at least 6 months prior to screening. For&#xD;
                  female subjects on the study, the vasectomized male partner should be their sole&#xD;
                  partner.&#xD;
&#xD;
               4. Double barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps)&#xD;
                  with spermicidal foam/gel/film/cream/vaginal suppository.&#xD;
&#xD;
               5. Oral*/ injected/ implanted/ transdermal hormonal contraception or other forms of&#xD;
                  hormonal contraception that have comparable efficacy (failure rate &lt;1%), e.g.,&#xD;
                  hormone vaginal ring.&#xD;
&#xD;
               6. Intrauterine device or intrauterine system. *Stable oral contraception use (on&#xD;
                  the same pill) for a minimum of 3 months before taking study treatment.&#xD;
&#xD;
             Women are considered post-menopausal and not of child-bearing potential if they have&#xD;
             had 12 consecutive months of natural (spontaneous) amenorrhea with an appropriate&#xD;
             clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had&#xD;
             surgical hysterectomy and/or bilateral oophorectomy or tubal ligation at least six&#xD;
             weeks ago.&#xD;
&#xD;
         10. Estimated life expectancy of at least 6 months, in the Investigator's opinion&#xD;
&#xD;
         11. Willing and able to comply with scheduled visits, study assessments and laboratory&#xD;
             tests, and other study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling to allow removal of tumor biological samples for analysis, i.e., biopsies of&#xD;
             tumor lesions, and/or collection of ascites fluid from abdominal ascites (if present)&#xD;
&#xD;
          2. Non epithelial tumor, including malignant mixed Müllerian tumors without high grade&#xD;
             serous component, or ovarian tumors with low malignant potential (i.e., borderline&#xD;
             tumors)&#xD;
&#xD;
          3. Known presence of central nervous system metastases&#xD;
&#xD;
          4. Presence of tumor metastases causing significant pleural disease/effusion unilaterally&#xD;
             or bilaterally (significant pleural effusion is defined by need for thoracentesis more&#xD;
             frequently than once every 21 days)&#xD;
&#xD;
          5. Presence of ascites that requires paracentesis more frequently than once every 21&#xD;
             days.&#xD;
&#xD;
          6. A history of another primary cancer that has been active or treated within the past 3&#xD;
             years prior to start of study treatment, with the exception of adequately&#xD;
             treated/resected: basal cell or squamous cell skin carcinoma or actinic keratoses; or&#xD;
             carcinoma in situ of the breast or of the cervix; or non-invasive malignant colon&#xD;
             polyps&#xD;
&#xD;
          7. Persistent toxic effects with severity of CTCAE grade 2 or greater (excluding&#xD;
             alopecia) caused by previous treatment&#xD;
&#xD;
          8. History of arterial or deep venous thromboembolism within the 12 months prior to&#xD;
             enrollment&#xD;
&#xD;
          9. Clinically significant cardiac disease, including:&#xD;
&#xD;
               1. Myocardial infarction or unstable angina &lt; 6 months prior to enrollment&#xD;
&#xD;
               2. New York Heart Association (NYHA) Grade II or greater congestive heart failure&#xD;
&#xD;
               3. Cardiac arrhythmia requiring medication (does not include asymptomatic atrial&#xD;
                  fibrillation with controlled ventricular rate)&#xD;
&#xD;
         10. Electrocardiogram (ECG) obtained at Screening which shows QTc prolongation or other&#xD;
             medically relevant abnormalities which may affect subject safety or interpretation of&#xD;
             study results&#xD;
&#xD;
         11. At a higher than average risk, in the Investigator's opinion, of bowel perforation&#xD;
             (e.g., symptoms of partial or complete bowel obstruction, recent (within 6 months)&#xD;
             history of fistula or bowel perforation, requirement for total parenteral nutrition&#xD;
             and continuous hydration)&#xD;
&#xD;
         12. Active or chronic recurrent systemic infections that require continuous antimicrobial&#xD;
             therapy during the Kevetrin study period&#xD;
&#xD;
         13. Past medical history of infection with HIV, hepatitis B or hepatitis C&#xD;
&#xD;
         14. Ongoing or recent history of any other uncontrolled and/or clinically significant&#xD;
             systemic disease or condition which, in the Investigator's medical opinion, should&#xD;
             exclude participation in the study&#xD;
&#xD;
         15. Less than 3 weeks between major surgery and planned start of study treatment; major&#xD;
             incisions must have healed&#xD;
&#xD;
         16. Less than 4 weeks since last treatment for ovarian cancer&#xD;
&#xD;
         17. Any investigational or experimental therapy or procedure or participation in any&#xD;
             interventional trial within 4 weeks or 5 half-lives (whichever is longer) prior to&#xD;
             start of study treatment&#xD;
&#xD;
         18. Women of child-bearing potential who are pregnant or nursing (lactating)&#xD;
&#xD;
         19. Previous participation in a clinical study of Kevetrin&#xD;
&#xD;
         20. History of alcohol or substance abuse, unless in full remission for more than 6 months&#xD;
             prior to start of study treatment&#xD;
&#xD;
         21. Any other severe acute or chronic medical or psychiatric condition or test&#xD;
             abnormality(ies) that, in the Investigator's opinion, puts the subject at significant&#xD;
             risk, could confound the study results, or may interfere significantly with the&#xD;
             subject's participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur Bertolino, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cellceutix Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Research</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>November 6, 2018</results_first_submitted>
  <results_first_submitted_qc>December 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 27, 2018</results_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03042702/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>No participants were enrolled in the &quot;Kevetrin 350 mg/m2 IV&quot;/&quot;Cohort 2&quot; Arm/Group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Kevetrin 250 mg/m2 IV/Cohort 1</title>
          <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Kevetrin 250 mg/m2 IV/Cohort 1</title>
          <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>54 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>71 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events</title>
        <description>Reporting of Adverse Events, and severity of adverse events</description>
        <time_frame>6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kevetrin 250 mg/m2 IV/Cohort 1</title>
            <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events</title>
          <description>Reporting of Adverse Events, and severity of adverse events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Changes in Biomarkers</title>
        <description>Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)</description>
        <time_frame>3 Weeks</time_frame>
        <population>All</population>
        <group_list>
          <group group_id="O1">
            <title>Kevetrin 250 mg/m2 IV/Cohort 1</title>
            <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Changes in Biomarkers</title>
          <description>Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)</description>
          <population>All</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed biomarker changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No observed biomarker changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants by RECIST Tumor Response Category</title>
        <description>Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.&#xD;
CR (Complete Response): Disappearance of all target lesions PR (Partial Response) : At least a 30% decrease in the sum of the longest diameters of target lesions PD (Progressive Disease) : At least a 20% increase in the sum of the longest diameters of target lesions SD (Stable Disease) : Small changes that do not meet above criteria</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kevetrin 250 mg/m2 IV Cohort 1</title>
            <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants by RECIST Tumor Response Category</title>
          <description>Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.&#xD;
CR (Complete Response): Disappearance of all target lesions PR (Partial Response) : At least a 30% decrease in the sum of the longest diameters of target lesions PD (Progressive Disease) : At least a 20% increase in the sum of the longest diameters of target lesions SD (Stable Disease) : Small changes that do not meet above criteria</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5</title>
        <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
        <time_frame>Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kevetrin 250 mg/m2 IV Cohort 1</title>
            <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5</title>
          <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
          <units>ng/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject 002-001 Cmax Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-001 Cmax Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-002 Cmax Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-002 Cmax Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5</title>
        <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
        <time_frame>Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kevetrin 250 mg/m2 IV Cohort 1</title>
            <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5</title>
          <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
          <units>hours</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject 002-001 Tmax Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-001 Tmax Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-002 Tmax Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-002 Tmax Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5</title>
        <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
        <time_frame>Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Kevetrin 250 mg/m2 IV Cohort 1</title>
            <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5</title>
          <description>Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.</description>
          <units>hours*ng/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject 002-001 AUCt Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-001 AUCt Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-002 AUCt Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject 002-002 AUCt Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from Screening thru End of Study. approximately 6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1</title>
          <description>Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends&#xD;
Kevetrin: Kevetrin dose to associated cohort</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Arthur P. Bertolino MD, PhD, MBA</name_or_title>
      <organization>Innovation Pharmaceuticals</organization>
      <phone>9789214125</phone>
      <email>abertolino@IPharmInc.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03042702
org study id: CTIX-KEV-201
nct id: NCT03042702
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an
      anti-proliferative p53 activator pharmacological class, for the treatment of cancer.
      Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild
      type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.

      In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be
      evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to
      evaluate the pharmacokinetics of Kevetrin when administered to subjects with
      platinum-resistant/refractory ovarian cancer.
This is an open label, dose-escalation trial to study the safety, biomarker changes
      (including modulation of p53), objective tumor response changes, and pharmacokinetics
      following administration of two different treatment regimens of Kevetrin over a 3-week period
      to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of
      Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin
      treatment. Standard of care treatment, as medically appropriate and per local guidelines,
      outside of this study protocol can commence after the collection of the post-Kevetrin
      treatment biomarker samples (collected on Day 21±1 day). The patient population recruited
      into this study includes those ovarian cancer patients that have platinum
      resistant/refractory disease, defined as disease progression/relapse within 6 months
      following the last administered dose of platinum therapy (resistant), or lack of response or
      disease progression while receiving the most recent platinum based therapy (refractory),
      respectively. Patients may or may not have had additional treatment (e.g., Doxil) prior to
      entry in this study.

      A total of approximately 10 study participants are planned to be enrolled in two cohorts of
      approximately 5 subjects per cohort, with enrollment in a sequential, dose-escalating
      fashion. Investigators and subjects will be aware of the treatment cohort into which they are
      recruiting. Cohort details and the planned doses are:

      Cohort 1 (n=5) Kevetrin Cycle - Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3
      doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses); Follow-up for
      3 weeks after Kevetrin treatment ends Cohort 2 (n=5) Kevetrin Cycle - Kevetrin 350 mg/m2 IV
      per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks
      (single cycle; total 9 doses); Follow-up for 3 weeks after Kevetrin treatment ends Cohorts 1
      and 2 will be conducted in a sequential fashion, with safety data from cohort 1 evaluated by
      an independent Data Monitoring Committee (DMC). The DMC will make appropriate recommendations
      based on the available safety data as regards the intent of progressing to the higher dose
      cohort 2.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Treatment-Emergent Adverse Events
time frame: 6 Weeks
description: Reporting of Adverse Events, and severity of adverse events
measure: Number of Participants With Changes in Biomarkers
time frame: 3 Weeks
description: Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)
measure: Number of Participants by RECIST Tumor Response Category
time frame: 3 Weeks
description: Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR (Complete Response): Disappearance of all target lesions PR (Partial Response) : At least a 30% decrease in the sum of the longest diameters of target lesions PD (Progressive Disease) : At least a 20% increase in the sum of the longest diameters of target lesions SD (Stable Disease) : Small changes that do not meet above criteria
measure: Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5
time frame: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
description: Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
measure: Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5
time frame: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
description: Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5
time frame: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour
description: Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
arm group label: Kevetrin 250 mg/m2 IV Cohort 1
arm group type: Experimental
description: Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
arm group label: Kevetrin 350 mg/m2 IV Cohort 2
arm group type: Experimental
description: Kevetrin 350 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (1050 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
intervention type: Drug
intervention name: Kevetrin
description: Kevetrin dose to associated cohort
arm group label: Kevetrin 250 mg/m2 IV Cohort 1
other name: Cohort
intervention type: Drug
intervention name: Kevetrin
description: Kevetrin dose to associated cohort
arm group label: Kevetrin 350 mg/m2 IV Cohort 2
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Arthur Bertolino, MD
role: Study Director
affiliation: Cellceutix Corporation
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 