<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/NCT01715168</url>
  </required_header>
  <id_info>
    <org_study_id>ATI0918-101</org_study_id>
    <nct_id>NCT01715168</nct_id>
  </id_info>
  <brief_title>A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer</brief_title>
  <official_title>A Phase 1, Single-blind, Randomized, Two-way, Crossover Bioequivalence Study of Intravenously Administered ATI 0918 in Patients With Ovarian Cancer That Has Progressed or Recurred After Platinum-based Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azaya Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azaya Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find the answers to the following research question(s):&#xD;
&#xD;
      1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same&#xD;
      way in the body as the approved drug?&#xD;
&#xD;
      ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to&#xD;
      prove. All people who participate in this study will receive the research study medication&#xD;
      (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).&#xD;
&#xD;
      The study drug being tested in this study works the same as the FDA (government) approved&#xD;
      drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being&#xD;
      delivered (given to the patient).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx</measure>
    <time_frame>pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days)</time_frame>
    <description>The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Cmax in a single dose of ATI0918 vs single dose of Doxil/Caelyx</measure>
    <time_frame>pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days)</time_frame>
    <description>The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Malignant Female Reproductive System Neoplasm</condition>
  <condition>Cancer</condition>
  <condition>Ovarian Tumor</condition>
  <condition>Ovarian Epithelial Cancer Recurrent</condition>
  <arm_group>
    <arm_group_label>DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATI-0918</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DOXIL/CAELYX</intervention_name>
    <arm_group_label>DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)</arm_group_label>
    <other_name>Doxorubicin Hydrochloride</other_name>
    <other_name>Doxil</other_name>
    <other_name>Caelyx</other_name>
    <other_name>Liposomal doxorubicin hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATI-0918</intervention_name>
    <arm_group_label>ATI-0918</arm_group_label>
    <other_name>doxorubicin hydrochloride</other_name>
    <other_name>liposomal doxorubicin hydrochloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have histologically confirmed ovarian cancer that is potentially sensitive to&#xD;
             DOXIL/CAELYX&#xD;
&#xD;
          2. Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one&#xD;
             of which was platinum based.&#xD;
&#xD;
          3. Be DOXIL/CAELYX treatment naïve&#xD;
&#xD;
          4. Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.&#xD;
&#xD;
          5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of &lt;/= 2&#xD;
&#xD;
          6. Have an estimated life expectancy of ≥ 3 months&#xD;
&#xD;
          7. Be &gt;/= 18 and &lt;/= 70 years of age&#xD;
&#xD;
          8. Sign a written Institutional Review Board (IRB)-approved informed consent form&#xD;
&#xD;
          9. Have a negative pregnancy test, if patient is of child-bearing potential&#xD;
&#xD;
         10. Have acceptable liver function:&#xD;
&#xD;
               -  Bilirubin &lt;/= upper limit of normal (ULN)&#xD;
&#xD;
               -  AST (SGOT), ALT (SGPT) and Alkaline phosphatase &lt;/= 1.5 times upper limit of&#xD;
                  normal&#xD;
&#xD;
         11. Have acceptable renal function:&#xD;
&#xD;
               -  Serum creatinine within normal limits, OR calculated creatinine clearance &gt;/= 60&#xD;
                  mL/min/1.73 m2 for patients with creatinine levels above institutional normal.&#xD;
&#xD;
         12. Have acceptable hematologic status:&#xD;
&#xD;
               -  Neutrophils &gt;/= 1500 cells/mm3&#xD;
&#xD;
               -  Platelet count &gt;/= 100,000 (plt/mm3)&#xD;
&#xD;
               -  Hemoglobin &gt;/= 9 g/dL&#xD;
&#xD;
         13. Have acceptable coagulation status:&#xD;
&#xD;
               -  Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN&#xD;
&#xD;
               -  Partial thromboplastin time (PTT) within 1.5 × ULN&#xD;
&#xD;
         14. Agree to use effective contraceptive methods during the study (nonsterile patients of&#xD;
             childbearing potential)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial&#xD;
             infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence&#xD;
             of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days&#xD;
             prior to Day 1&#xD;
&#xD;
          2. Have received &gt; 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or&#xD;
             similar compounds&#xD;
&#xD;
          3. Have received prior treatment with DOXIL/CAELYX&#xD;
&#xD;
          4. Have received radiotherapy to the mediastinal area or concomitant therapy with other&#xD;
             potentially cardiotoxic agents&#xD;
&#xD;
          5. Have seizure disorders requiring anticonvulsant therapy&#xD;
&#xD;
          6. Have known brain metastases (unless previously treated and well controlled for a&#xD;
             period of &gt;/= 3 months)&#xD;
&#xD;
          7. Have severe chronic obstructive pulmonary disease with hypoxemia&#xD;
&#xD;
          8. Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1&#xD;
&#xD;
          9. Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic&#xD;
             infections requiring systemic therapy&#xD;
&#xD;
         10. Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must agree&#xD;
             to use adequate contraception (hormonal or barrier method of birth control; or&#xD;
             abstinence) prior to study entry and for the duration of study participation. Should a&#xD;
             woman become pregnant or suspect she is pregnant while participating in this study,&#xD;
             she must inform her treating physician immediately.&#xD;
&#xD;
         11. Have received treatment with radiation therapy, surgery, chemotherapy, or&#xD;
             investigational therapy within one month prior to study entry (6 weeks for&#xD;
             nitrosoureas or Mitomycin C).&#xD;
&#xD;
         12. Have received radiation therapy to &gt;25% of her total bone marrow during her lifetime&#xD;
&#xD;
         13. Are unwilling or unable to comply with procedures required in this protocol&#xD;
&#xD;
         14. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or&#xD;
             hepatitis C&#xD;
&#xD;
         15. Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure,&#xD;
             significantly impaired hepatic function, or other conditions) that could compromise&#xD;
             protocol objectives in the opinion of the investigator and/or the sponsor&#xD;
&#xD;
         16. Are currently receiving any other investigational agent&#xD;
&#xD;
         17. Have exhibited allergic reactions to doxorubicin or a similar structural compound&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yakima Valley Memorial Hospital - North Star Lodge</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de L'Universite de Montreal (CHUM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>January 13, 2015</last_update_submitted>
  <last_update_submitted_qc>January 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Doxil generic</keyword>
  <keyword>Caelyx generic</keyword>
  <keyword>generic treatment</keyword>
  <keyword>ovarian cancer</keyword>
  <keyword>ovary</keyword>
  <keyword>progressed</keyword>
  <keyword>recurred cancer</keyword>
  <keyword>platinum based therapy</keyword>
  <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>
    <mesh_term>Genital Neoplasms, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01715168
org study id: ATI0918-101
nct id: NCT01715168
lead sponsor: 
has dmc: No
The purpose of this study is to find the answers to the following research question(s):

      1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same
      way in the body as the approved drug?

      ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to
      prove. All people who participate in this study will receive the research study medication
      (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).

      The study drug being tested in this study works the same as the FDA (government) approved
      drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being
      delivered (given to the patient).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx
time frame: pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days)
description: The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.
measure: Comparison of Cmax in a single dose of ATI0918 vs single dose of Doxil/Caelyx
time frame: pre, 30 min + pre, 0, .50, 1, 2, 4, 6, 24, 48, 72, 120, 168, 216 hour post infusion for 2 Cycles (Cycle is defined as 28 days)
description: The primary objective of this study is to determine the pharmacokinetic equivalence of ATI-0918 and DOXIL/CAELYX as a single dose in patients with ovarian cancer. The outcome measure will be determined by analyzing PK data from drawn from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (Cmax)to determine % variability between ATI0918 and Doxil/Caelyx within each patient.
arm group label: DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)
arm group type: Active Comparator
description: Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil)
arm group label: ATI-0918
arm group type: Experimental
description: Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis
intervention type: Drug
intervention name: DOXIL/CAELYX
arm group label: DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)
other name: Doxorubicin Hydrochloride
other name: Doxil
other name: Caelyx
other name: Liposomal doxorubicin hydrochloride
intervention type: Drug
intervention name: ATI-0918
arm group label: ATI-0918
other name: doxorubicin hydrochloride
other name: liposomal doxorubicin hydrochloride
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Genital Neoplasms, Female
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin