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

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

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Docetaxel Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Prednisone Abiraterone CB 7630

U.S. FDA Resources

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

Further study details as provided by Cougar Biotechnology:

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/equal to 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 36 Study Locations

Sponsors and Collaborators

Cougar Biotechnology

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

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

Responsible Party:	Cougar Biotechnology, Inc. ( Christopher M. Haqq MD PhD )
Study ID Numbers:	COU-AA-301
First Received:	March 13, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00638690
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:

Metastatic Castration Resistant Prostate Cancer

CRPC

Abiraterone Acetate

CB7630

Study placed in the following topic categories:

Docetaxel

Prednisone

Prostatic Diseases

Genital Neoplasms, Male

Methylprednisolone

Prednisolone

Methylprednisolone acetate

Prednisolone acetate

Urogenital Neoplasms

Prostatic Neoplasms

Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Genital Diseases, Male

Protective Agents

Neuroprotective Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on July 03, 2008

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