Overview

This trial is active, not recruiting.

Conditions ovarian cancer, malignant female reproductive system neoplasm, cancer, ovarian tumor, ovarian epithelial cancer recurrent
Treatments doxil/caelyx, ati-0918
Phase phase 1
Sponsor Azaya Therapeutics, Inc.
Start date October 2012
End date October 2015
Trial size 40 participants
Trial identifier NCT01715168, ATI0918-101

Summary

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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil)
doxil/caelyx Doxorubicin Hydrochloride
(Experimental)
Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis
ati-0918 doxorubicin hydrochloride

Primary Outcomes

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)
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)

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria

  • Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
  • Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
  • Be DOXIL/CAELYX treatment naïve
  • Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of </= 2
  • Have an estimated life expectancy of ≥ 3 months
  • Be >/= 18 and </= 70 years of age
  • Sign a written Institutional Review Board (IRB)-approved informed consent form
  • Have a negative pregnancy test, if patient is of child-bearing potential
  • Have acceptable liver function:
    • Bilirubin </= upper limit of normal (ULN)
    • AST (SGOT), ALT (SGPT) and Alkaline phosphatase </= 1.5 times upper limit of normal
  • 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.
  • Have acceptable hematologic status:
    • Neutrophils >/= 1500 cells/mm3
    • Platelet count >/= 100,000 (plt/mm3)
    • Hemoglobin >/= 9 g/dL
  • Have acceptable coagulation status:
    • Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN
    • Partial thromboplastin time (PTT) within 1.5 × ULN
  • Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)

Exclusion Criteria

  • 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
  • Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
  • Have received prior treatment with DOXIL/CAELYX
  • Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
  • Have seizure disorders requiring anticonvulsant therapy
  • Have known brain metastases (unless previously treated and well controlled for a period of >/= 3 months)
  • Have severe chronic obstructive pulmonary disease with hypoxemia
  • Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
  • Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
  • 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.
  • 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).
  • Have received radiation therapy to >25% of her total bone marrow during her lifetime
  • Are unwilling or unable to comply with procedures required in this protocol
  • Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • 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
  • Are currently receiving any other investigational agent
  • Have exhibited allergic reactions to doxorubicin or a similar structural compound

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Azaya Therapeutics, Inc..