A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy

Cougar Biotechnology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: Abiraterone acetate; Drug: Abiraterone acetate MTD; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00473512

COU-AA-001 (Other Identifier)

CR016909

Details and patient eligibility

About

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose [MTD]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).

Full description

This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with HRPC. The study will consist of a dose escalation stage (Phase 1) that will be conducted to determine the MTD of abiraterone and an activity evaluation stage (Phase 2) to evaluate the activity of abiraterone in participants with HRPC. Escalated doses of abiraterone (starting at 250 milligram [mg] up to a maximum of 2000 mg) will be given for 28-day treatment periods to determine the MTD. Participants will be given MTD of abiraterone for up to 12 cycles (28 day each) in Phase 2 of the study. Participants' safety will be monitored throughout the study.

Enrollment: 54 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically (pertaining to the disease status of body tissues or cells) documented adenocarcinoma of the prostate, clinically refractory (not responding to treatment) or resistant to hormone therapy, as documented by progression following at least one hormonal therapy
• Prostate specific antigen (PSA) evidence for progressive prostate cancer
• Participants who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir(value) greater than or equal to 4 weeks from treatment withdrawal if treated with flutamide and greater than or equal to 6 weeks if treated with bicalutamide or nilutamide
• Eastern Cooperative Oncology Group (ECOG) performance status score equal to 0 or 1
• Life expectancy of greater than or equal to12 week

Exclusion criteria

• Participants with central nervous system (the brain and spinal cord) disease and/or brain metastases
• No currently active second malignancy (cancer or other progressively enlarging and spreading tumor) other than non-melanoma skin cancer
• Myocardial infarction within the 6 months prior to start of study
• No active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy during protocol treatment
• Major surgery or significant traumatic injury within 4 weeks of start of study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Abiraterone acetate

Experimental group

Description:

Abiraterone acetate 250 mg up to a maximum of 2000 mg capsules will be given orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants will receive MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg will be given orally (If participants have disease progression) daily up to 12 cycles.

Treatment:

Drug: Abiraterone acetate MTD

Drug: Abiraterone acetate

Drug: Dexamethasone