Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005401

Trial Description

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Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus
prednisone with placebo plus prednisone in patients with metastatic castration-resistant
prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the
previous chemotherapies must have contained docetaxel.

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Brief Summary in Scientific Language

Abiraterone acetate is a steroidal irreversible inhibitor of CYP17 (17α hydroxylase/C17,
20-lyase), blocking 2 important enzymatic activities in the synthesis of testosterone. The
goal of this study is to compare the clinical benefit of abiraterone acetate plus prednisone
with placebo plus prednisone in patients with metastatic castration-resistant prostate
cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains
docetaxel. All patients involved in the study will be randomized (assigned by chance) into
one of two arms and will not know what study drug is being given to them. Study drug
randomization allocation will be 2:1 (abiraterone acetate: placebo). The study will be
conducted in the United States, Canada, Australia, and the EU. The study will consist of
screening, treatment, and follow-up. In this study, patients will receive study treatment
(abiraterone acetate or placebo) plus prednisone until progression of clinical disease.
Follow-up will continue until patient dies, is lost to follow-up, or withdraws informed
consent. After providing written informed consent, patients will have screening procedures
completed to determine eligibility. Safety evaluations at the screening procedure will
include a physical examination, vital signs, and clinical blood laboratory tests, ECG,
radiographs, urine tests, and recording of any adverse events including details of current
prostate cancer symptoms. Patients will be asked to use a method of birth control with
adequate barrier protection as determined to be acceptable by the principal investigator and
sponsor during the study and for 13 weeks after last study drug administration.

Study medication, abiraterone acetate,is an oral (by mouth) medication to be administered as
four (4) 250mg abiraterone acetate tablets or 4 placebo tablets to be taken at least one
hour before or two hours after a meal anytime up to 10PM everyday. Prednisone will be
administered as 5mg orally twice a day for both groups. Each cycle will be 28 days. Study
treatment will continue until disease progression as determined by investigator or when the
patient meets criteria for withdrawal from study.

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Organizational Data

  •   DRKS00005401
  •   2013/11/05
  •   2008/03/13
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00638690  (ClinicalTrials.gov)
  •   CR016924  (Cougar Biotechnology, Inc.)
  •   COU-AA-301 
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Health Condition or Problem studied

  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Placebo
  •   Drug: Abiraterone acetate
  •   Drug: Prednisone/prednisolone
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Overall Survival; time frame: Up to 60 months; Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.

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Secondary Outcome

- Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria; time frame: Up to 12 months; The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
- Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%; time frame: Up to 12 months; A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.
- Radiographic Progression-free Survival; time frame: Up to 11 months; Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   France
  •   Germany
  •   Hungary
  •   Ireland
  •   Netherlands
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2008/05/31
  •   1195
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior
cytotoxic chemotherapies

- At least one chemotherapy must have contained docetaxel

- Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2

- Medical or surgical castration with testosterone < 50 ng/dL

- Adequate bone marrow, hepatic and renal function

- Potassium >= 3.5 mmol/L

- Able to swallow the study drug whole as a tablet

- Informed Consent

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Exclusion Criteria

- More than two prior cytotoxic chemotherapy regimens

- 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

- Not willing to use contraception

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Cougar Biotechnology, Inc.
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    •   [---]*
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    • Cougar Biotechnology, Inc.
    • Cougar Biotechnology, Inc Clinical Trial 
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    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Cougar Biotechnology, Inc.
    • Cougar Biotechnology, Inc Clinical Trial 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/10/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.