Phase 2
Completed N=54
A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy
Source: ClinicalTrials.gov NCT00473512 ↗Enrolled (actual)
54
Serious AEs
48.2%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 — 10; 25 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 |
10; 25 | — |
| SECONDARY Number of Participants With Objective Tumor Response |
0; 8 | — |
| SECONDARY Duration of Prostate Specific Antigen (PSA) Response |
141 | — |
| SECONDARY Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) |
— | — |
| SECONDARY Time to Disease Progression |
— | — |
| SECONDARY Overall Survival |
— | — |
Eligibility Criteria
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- Participants who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA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
Data sourced from ClinicalTrials.gov (NCT00473512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.