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

Cougar Biotechnology, Inc.54 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

Abiraterone acetateDRUG

Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.

Abiraterone acetate MTDDRUG

Abiraterone acetate MTD orally for 12 cycles (28 day each).

DexamethasoneDRUG

Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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one hormonal therapy * Prostate specific antigen (PSA) evidence for progressive prostate cancer * Participants who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA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

Locations (1)

Unnamed facility

Sutton, United Kingdom

Outcomes

Primary Outcomes

Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12

The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.

Time frame: Baseline, Week 12

Secondary Outcomes

Number of Participants With Objective Tumor Response

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.

Time frame: Baseline up to end of study (1160 days)

Duration of Prostate Specific Antigen (PSA) Response

Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.

Time frame: Baseline up to end of study (1160 days)

Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)

Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.

Data from ClinicalTrials.gov

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