At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell histology
- ✓Prior chemotherapy with paclitaxel or docetaxel
- ✓PSA progression with PSA >5 ng/mL per PSA working group criteria
- ✓Ongoing androgen deprivation with testosterone <50 ng/dL
- ✕Active or uncontrolled autoimmune disease requiring corticosteroid therapy
- ✕Serious or uncontrolled co-existent non-malignant disease including active uncontrolled infection
- ✕Uncontrolled hypertension
- ✕Clinically significant heart disease including myocardial infarction in past 12 months, severe/unstable angina, or NYHA Class III-IV heart disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Abiraterone acetate and Glucocorticoid for Prostate Neoplasms. Completed, enrolled 47 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland \[a gland in the male reproductive system found below the bladder and in front of the rectum\] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.
Study Details
Timeline
Interventions
Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.
Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.