A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer

January 13, 2015 updated by: Azaya Therapeutics, Inc.

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L4M1
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • United States
    • Washington
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital - North Star Lodge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
  2. Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
  3. Be DOXIL/CAELYX treatment naïve
  4. Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
  5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
  6. Have an estimated life expectancy of ≥ 3 months
  7. Be >/= 18 and </= 70 years of age
  8. Sign a written Institutional Review Board (IRB)-approved informed consent form
  9. Have a negative pregnancy test, if patient is of child-bearing potential

  10. Have acceptable liver function:

    • Bilirubin </= upper limit of normal (ULN)
    • AST (SGOT), ALT (SGPT) and Alkaline phosphatase </= 1.5 times upper limit of normal

  11. Have acceptable renal function:

    • Serum creatinine within normal limits, OR calculated creatinine clearance >/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

  12. Have acceptable hematologic status:

    • Neutrophils >/= 1500 cells/mm3
    • Platelet count >/= 100,000 (plt/mm3)
    • Hemoglobin >/= 9 g/dL

  13. Have acceptable coagulation status:

    • Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN
    • Partial thromboplastin time (PTT) within 1.5 × ULN
  14. Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)

Exclusion Criteria:

  1. Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days prior to Day 1
  2. Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
  3. Have received prior treatment with DOXIL/CAELYX
  4. Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
  5. Have seizure disorders requiring anticonvulsant therapy
  6. Have known brain metastases (unless previously treated and well controlled for a period of >/= 3 months)
  7. Have severe chronic obstructive pulmonary disease with hypoxemia
  8. Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
  9. Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
  10. Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  11. Have received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
  12. Have received radiation therapy to >25% of her total bone marrow during her lifetime
  13. Are unwilling or unable to comply with procedures required in this protocol
  14. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  15. Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  16. Are currently receiving any other investigational agent
  17. Have exhibited allergic reactions to doxorubicin or a similar structural compound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)
Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil)
Drug: DOXIL/CAELYX
Other Names:
  • Caelyx
  • Doxil
  • Doxorubicin Hydrochloride
  • Liposomal doxorubicin hydrochloride
Experimental: ATI-0918
Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis
Drug: ATI-0918
Other Names:
  • liposomal doxorubicin hydrochloride
  • doxorubicin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azaya Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI0918-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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