Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy - Full Text View

Sponsored by:	Cougar Biotechnology, Inc.
Information provided by:	Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT00638690

Purpose

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

Condition	Intervention	Phase
Metastatic Castration-Resistant Prostate Cancer	Drug: placebo plus prednisone/prednisolone Drug: abiraterone acetate plus prednisone/prednisolone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisolone Prednisolone acetate Prednisone Depo-medrol Medrol veriderm Methylprednisolone Docetaxel CB 7630 Abiraterone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Cougar Biotechnology, Inc.:

Primary Outcome Measures:

Overall Survival [ Time Frame: During the Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients achieving a PSA decline ≥ 50% according to Prostate Specific Antigen Working Group (PSAWG) criteria [ Time Frame: During Study Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	1158
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental abiraterone acetate plus prednisone/prednisolone	Drug: abiraterone acetate plus prednisone/prednisolone 1000mg Daily/5mg Twice Daily
2: Placebo Comparator placebo plus prednisone/prednisolone	Drug: placebo plus prednisone/prednisolone 1000mg Daily/5mg Twice Daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Major Inclusion Criteria:

Metastatic Castration-Resistant Prostate Cancer
Progression after one or two prior cytotoxic chemotherapies. At least one chemotherapy must have contained docetaxel
ECOG Performance Status less than/ equal to 2
Medical or surgical castration with testosterone less than 50 ng/dL
Adequate bone marrow, hepatic and renal function
Potassium greater than/ equal to 3.5 mmol/L
Able to swallow the study drug whole as a tablet
Informed Consent

Major 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638690

Show 152 Study Locations

Sponsors and Collaborators

Cougar Biotechnology, Inc.

Investigators

Study Chair:	Howard I Scher, MD	Memorial Sloan-Kettering Cancer Center
Study Chair:	JS de Bono, MD FRCP PhD	ICR/Royal Marsden Hospital

More Information

Additional Information:

COUGAR BIOTECHNOLOGY This link exits the ClinicalTrials.gov site

AMERICAN SOCIETY OF CLINICAL ONCOLOGY This link exits the ClinicalTrials.gov site

NATIONAL CANCER INSTITUTE This link exits the ClinicalTrials.gov site

NATIONAL INSTITUTE OF HEALTH This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cougar Biotechnology, Inc. ( Christopher M. Haqq MD PhD )
Study ID Numbers:	COU-AA-301
Study First Received:	March 13, 2008
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00638690 History of Changes
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: National Health and Medical Research Council; Canada: Health Canada

Keywords provided by Cougar Biotechnology, Inc.:

Metastatic Castration Resistant Prostate Cancer
CRPC
Abiraterone Acetate
CB7630

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Urogenital Neoplasms

Prednisolone acetate
Genital Diseases, Male
Neuroprotective Agents
Hormones
Glucocorticoids
Docetaxel
Prednisolone
Peripheral Nervous System Agents
Prostatic Neoplasms
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Prostatic Diseases
Genital Neoplasms, Male
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Urogenital Neoplasms
Neuroprotective Agents
Hormones
Neoplasms by Site
Therapeutic Uses

Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Methylprednisolone acetate
Genital Diseases, Male
Protective Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009