<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/NCT01690468</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-18641</org_study_id>
    <nct_id>NCT01690468</nct_id>
  </id_info>
  <brief_title>PTX-200 and Carboplatin in Ovarian Cancer</brief_title>
  <official_title>A Phase IA/IB Trial of PTX-200 and Carboplatin in Patients With Platinum-Resistant Recurrent Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prescient Therapeutics, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prescient Therapeutics, Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe&#xD;
      and tolerable when given together, and to determine if this combination of drugs can help&#xD;
      people with recurrent ovarian cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the safety and tolerability, and determine the&#xD;
      maximum tolerated dose of triciribine when combined with carboplatin in women with&#xD;
      platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to&#xD;
      evaluate the clinical activity of carboplatin plus triciribine in women with&#xD;
      recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate,&#xD;
      progression-free survival, and duration of stable disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment stopped prior to Phase 1b, change in strategic focus&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD)</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>2 years</time_frame>
    <description>The best overall response is the best time point response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest sum recorded since baseline).&#xD;
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10mm.&#xD;
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>2 years</time_frame>
    <description>Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.&#xD;
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).&#xD;
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Stable Disease (SD)</measure>
    <time_frame>2 years</time_frame>
    <description>Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.&#xD;
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Triciribine &amp; Carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I/II: 25mg/m^2 Triciribine and Carboplatin AUC 4. Triciribine escalated to 30, 35, 45mg/m^2 if toxicities are not encountered.&#xD;
Phase II: Recommended phase II dose of triciribine and carboplatin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triciribine</intervention_name>
    <description>Triciribine (15, 25, 30, 35, or 45 mg/m^2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.</description>
    <arm_group_label>Triciribine &amp; Carboplatin</arm_group_label>
    <other_name>triciribine phosphate monohydrate</other_name>
    <other_name>TCN</other_name>
    <other_name>TCN-PM</other_name>
    <other_name>AKT inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.</description>
    <arm_group_label>Triciribine &amp; Carboplatin</arm_group_label>
    <other_name>Paraplatin®</other_name>
    <other_name>NSC #241240</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Histologically confirmed, measurable or non-measurable, recurrent or persistent,&#xD;
             platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma.&#xD;
             By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is&#xD;
             defined by a disease-free interval of less than 6 months following treatment with a&#xD;
             platinum-based regimen, or the progression of disease during platinum-based therapy.&#xD;
&#xD;
          -  At least one prior regimen of chemotherapy, with no maximum number of chemotherapy&#xD;
             cycles&#xD;
&#xD;
          -  A serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry&#xD;
&#xD;
          -  Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000&#xD;
             mm^3; absolute neutrophil count ≥ 1500 mm^3; platelets ≥ 100,000 mm^3&#xD;
&#xD;
          -  Adequate hepatocellular function: aspartate aminotransferase (AST) and alanine&#xD;
             transaminase (ALT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤&#xD;
             1.5 mg/dl&#xD;
&#xD;
          -  Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2&#xD;
&#xD;
          -  Life expectancy of at least 90 days&#xD;
&#xD;
          -  The patient should be off chemotherapy, biologic therapy and radiation for 28 days.&#xD;
&#xD;
          -  Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity&#xD;
             Criteria (CTC) version 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior TCN-PM therapy&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to TCN-PM&#xD;
&#xD;
          -  Patients must be disease-free of prior invasive malignancies for &gt;2 years with the&#xD;
             exception of basal cell or squamous cell carcinoma of the skin.&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Corrected QT interval (QTc) prolongation &gt; 450 milliseconds (msec)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Wenham, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01690468
org study id: MCC-18641
nct id: NCT01690468
lead sponsor: 
has dmc: No
The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe
      and tolerable when given together, and to determine if this combination of drugs can help
      people with recurrent ovarian cancer.
The purpose of this study is to investigate the safety and tolerability, and determine the
      maximum tolerated dose of triciribine when combined with carboplatin in women with
      platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to
      evaluate the clinical activity of carboplatin plus triciribine in women with
      recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate,
      progression-free survival, and duration of stable disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD)
time frame: 6 months
description: To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).
measure: Overall Response Rate (ORR)
time frame: 2 years
description: The best overall response is the best time point response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest sum recorded since baseline).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
measure: Progression Free Survival (PFS)
time frame: 2 years
description: Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
measure: Duration of Stable Disease (SD)
time frame: 2 years
description: Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
arm group label: Triciribine & Carboplatin
arm group type: Experimental
description: Phase I/II: 25mg/m^2 Triciribine and Carboplatin AUC 4. Triciribine escalated to 30, 35, 45mg/m^2 if toxicities are not encountered.
Phase II: Recommended phase II dose of triciribine and carboplatin.
intervention type: Drug
intervention name: Triciribine
description: Triciribine (15, 25, 30, 35, or 45 mg/m^2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.
arm group label: Triciribine & Carboplatin
other name: triciribine phosphate monohydrate
other name: TCN
other name: TCN-PM
other name: AKT inhibitor
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.
arm group label: Triciribine & Carboplatin
other name: Paraplatin®
other name: NSC #241240
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Wenham, MD
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Carboplatin
sharing ipd: No