A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

• Status: Completed
• Trial end date: 2018-05-08
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when co-administered with prednisone in Asian patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Docetaxel; Prednisone

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate except neuroendocrine carcinoma including small cell carcinoma

• Disease progressed on or after prior docetaxel-containing chemotherapy

• Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer, at least 1 of which contains docetaxel

• Documented prostate cancer progression as documented by prostate specific antigen progression according to Prostate Specific Antigen Working Group criteria or radiographic progression in soft tissue or bone

• Surgically or medically castrated, with serum testosterone level <50 ng/dL (1.7 nmol/L)

• Eastern Cooperative Oncology Group performance status score of <=2

• Protocol-defined laboratory values

• Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

• Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated

• Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily

• Pathological finding consistent with neuroendocrine carcinoma of prostate including small cell carcinoma

• Uncontrolled hypertension (systolic BP >=160 mmHg or diastolic BP >=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy)

• Active or symptomatic viral hepatitis or chronic liver disease, have a known infection with human immunodeficiency virus and/or hepatitis B virus or hepatitis C virus

• History of pituitary or adrenal dysfunction.

• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of <50% at baseline

• Atrial fibrillation, or other cardiac arrhythmia requiring therapy

• Other malignancy within past 3 years (except basal or nonmetastatic squamous cell carcinoma of the skin)

• Known brain metastasis

• Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer

• Prior therapy with ketoconazole for prostate cancer

• Surgery or local prostatic intervention within 30 days of the first dose

• Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1

• Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute-Common Terminology Criteria for Adverse Events grade of <=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed)

• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1

• Anti-androgen treatment must not be given within 4 weeks (flutamide) or 6 weeks (bicalutamide or nilutamide) prior to Cycle 1 Day 1

• Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4 weeks prior to Cycle 1 Day 1

• Has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients

• Has contraindications to the use of prednisone per local prescribing information

• Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments