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

Status unconfirmed · Phase 1

Conditions studied: Ovarian Cancer, Malignant Female Reproductive System Neoplasm, Cancer, Ovarian Tumor, Ovarian Epithelial Cancer Recurrent

In brief

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).

Key facts

Study ID

NCT01715168

Run by

Azaya Therapeutics, Inc.

People needed

40

Starts

2012-10-01

Expected to finish

2015-12-01

Last updated by the study team

2015-01-15

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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