Ongoing Clinical Trials / Prostate Cancer - Abiraterone
Trial Information
Prostate Cancer: A Clinical Trial of Abiraterone for men who have stopped responding to Docetaxel [TAXOTERE®] based chemotherapy.
- Principal Investigator: Matthew Rettig, M.D.
- Co-Investigators: Allan Pantuck, M.D., Fairooz Kabbinavar, M.D., Steven Wong M.D.
This trial is currently accepting new patient applications
Objective:
A study testing the safety and efficacy of Abiraterone Acetate (CB7630) plus Prednisone in patients with metastatic castration resistant prostate cancer who have stopped responding to docetaxel based chemotherapy.
The purpose of this study is to evaluate the anti-tumor effects of Abiraterone acetate, also known as CB7630, given with prednisone (oral cortisone) in individuals who have metastatic prostate cancer and have stopped responding to chemotherapy.
It is hoped that Abiraterone acetate will slow down the growth of prostate cancer in men who have not responded to standard hormone therapy by decreasing the testosterone level produced by the adrenal glands. However, there is no guarantee that this will take place in you, or that this would prolong your life.
Trial Design
A Phase 3, Randomized, Placebo Controlled Study.
All participants will be randomly assigned to 1 of 2 treatment groups. You will have approximately a 67% chance (twice as likely) of receiving Abiraterone acetate in combination with prednisone and approximately a 33% chance of receiving placebo in combination with prednisone .The placebo looks like the Abiraterone acetate tablet but it does not contain Abiraterone acetate and will have no effect on your body. You, your study doctor, and the study staff will not know whether you are receiving Abiraterone acetate in combination with prednisone or placebo in combination with prednisone.
However, in the event of an emergency, the study can be unblinded and the intervention revealed.
\ Groups
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Intervention
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1: Experimental
Abiraterone
+
Prednisone
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Drug: Abiraterone
1000mg capsule once Daily and 5mg prednisone twice Daily
Cycles consist of 28 days
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2:Placebo Control
Placebo
+
prednisone
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Drug: Placebo
1000mg placebo once Daily and 5mg prednisone twice Daily
Cycles consist of 28 days
|
The number of cycles you participate in are up to you and your physician.
Patient Eligibility
Inclusion Criteria:
- Metastatic Castration-Resistant Prostate Cancer
- Progression of disease after one or two prior cytotoxic chemotherapies. At least one chemotherapy regimen must have contained docetaxel [TAXOTERE®]
- Medical or surgical castration with testosterone less than 50 ng/dL
- Adequate bone marrow, hepatic and renal function
Exclusion Criteria:
- Prior Ketoconazole for prostate cancer
- Prior Abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
For more information
For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call recruitment coordinator Diana Sarkisyan at (310) 206-7793 (dsarkisyan@mednet.ucla.edu) or Nazy Zomorodian, Director for the Clinical Trials Office at (310) 794-7704.
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