Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer - Full Text View

Sponsor:	Cougar Biotechnology, Inc.
Information provided by:	Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT00887198

Purpose

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: abiraterone acetate plus prednisone/prednisolone Drug: placebo plus prednisone/prednisolone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisolone Prednisolone acetate Prednisone Methylprednisolone acetate Methylprednisolone Prednisolone Sodium Phosphate Prednisolone phosphate Methylprednisolone Sodium Succinate Abiraterone acetate

U.S. FDA Resources

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

Primary Outcome Measures:

Overall Survival (OS) and Progression-Free Survival [ Time Frame: Every 3 months while on study and during follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	April 2009
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

Metastatic castration-resistant prostate cancer
Previous anti-androgen therapy and progression after withdrawal
ECOG performance status of either 0 or 1
Medical or surgical castration with testosterone less than 50 ng/dL
Able to provide written informed consent

Exclusion Criteria:

Prior cytotoxic chemotherapy or biologic therapy for CRPC
Prior ketoconazole for prostate cancer
Known brain metastasis or visceral organ metastasis
Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887198

Show 166 Study Locations

Sponsors and Collaborators

Cougar Biotechnology, Inc.

More Information

Additional Information:

Cougar Biotechnology, Inc. 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:	Thomas Griffin, MD, Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT00887198 History of Changes
Other Study ID Numbers:	CR016927, COU-AA-302
Study First Received:	April 18, 2009
Last Updated:	February 13, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Australia: National Health and Medical Research Council Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Greece: Ministry of Health and Welfare Italy: Ethics Committee Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Netherlands: Medicines Evaluation Board (MEB) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cougar Biotechnology, Inc.:

abiraterone acetate
CB7630
CRPC
metastatic castration-resistant prostate cancer
hormone refractory prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone
Prednisolone phosphate
Anti-Inflammatory Agents

Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 24, 2012