Prostate Neoplasms
Conditions
Keywords
Prostate neoplasms, Hormone refractory prostate cancer, Castration resistant prostate cancer, Castration refractory prostate cancer, Abiraterone acetate, CB7630
Brief summary
The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.
Detailed description
This is an open-label (identity of study drug will be known) extended access study to evaluate the safety and efficacy of continued administration of abiraterone acetate in patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will continue with the same dose regimen administered at the end of Study COU-AA-001 and will receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease progression and survival for up to 3 years following study entry. Safety will be monitored throughout the study up to 30 days after the last dose of study medication.
Interventions
DRUGAbiraterone acetate
Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily
DRUGGlucocorticoid
prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed 12 cycles of abiraterone acetate under study COU-AA-001 * Last dose of abiraterone acetate within 14 days prior to treatment in this study * Demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment * Serum potassium level \>=3.5 mmol/L * Eastern Cooperative Oncology Group Performance Status of \<3 (Karnofsky Performance Status \>=30%) * Agrees to protocol-defined use of effective contraception
Exclusion criteria
* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Uncontrolled hypertension * Abnormal liver function * Clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable) * Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria | Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry |
| Overall survival | every 3 months up to 3 years after study entry |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | up to 30 days after the last dose of study medication |
| Time to disease progression | every 3 months up to 3 years after study entry |
| Time to prostate specific antigen progression | every 3 months up to 3 years after study entry |
| Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) | every 3 months up to 3 years after study entry |
Countries
United Kingdom
Outcome results
None listed