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

NCT01715168 | Unknown Phase 1

• 1 other identifier: ATI0918-101
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief 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).

Conditions

Ovarian Cancer; Malignant Female Reproductive System Neoplasm; Cancer; Ovarian Tumor; Ovarian Epithelial Cancer Recurrent

Keywords

Doxil generic; Caelyx generic; generic treatment; ovarian cancer; ovary; progressed; recurred cancer; platinum based therapy

Outcome Measures

Primary Outcomes (2)

• Comparison of AUC in a single dose of ATI0918 vs single dose of Doxil/Caelyx

  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

  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)

Study Arms (2)

DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)

ACTIVE COMPARATOR

Current Standard of care and/or reference product in Europe (Caelyx) and US (Doxorubicin Hydrochloride (Liposome) and Doxil)

Drug: DOXIL/CAELYX

ATI-0918

EXPERIMENTAL

Investigational drug arm which will be compared to Doxil/Caelyx and Hydrochloride Doxorubicin (Liposome) arms for bioequivalence analysis

Drug: ATI-0918

Interventions

DOXIL/CAELYX DRUG

Also known as: Doxorubicin Hydrochloride, Doxil, Caelyx, Liposomal doxorubicin hydrochloride

DOXIL/CAELYX or Doxorubicin Hydrochloride (Lipspome)

ATI-0918 DRUG

Also known as: doxorubicin hydrochloride, liposomal doxorubicin hydrochloride

ATI-0918

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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

Sponsors & Collaborators

• Azaya Therapeutics, Inc.: lead

Study Sites (2)

Yakima Valley Memorial Hospital - North Star Lodge

Yakima, Washington, 98902, United States

Location

Centre Hospitalier de L'Universite de Montreal (CHUM)

Montreal, Quebec, H2L4M1, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

liposomal doxorubicin; Doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

CA (1); US (1)