Clinical trial · Interventional
An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001
An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001
NCT01664728CI-TRIAL-00010091completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Glucocorticoid | Drug | Therapeutic Glucocorticoid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abiraterone acetate
- interventionNames
- Drug: Abiraterone acetate
- Drug: Glucocorticoid
Primary outcomes (2)
- measure
- Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
- timeFrame
- Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry
- measure
- Overall survival
- timeFrame
- every 3 months up to 3 years after study entry
Secondary outcomes (4)
- measure
- Number of participants with adverse events
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.