Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Clinical Study of Abiraterone Acetate and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
This study is ongoing, but not recruiting participants.
Sponsored by: Cougar Biotechnology
Information provided by: Cougar Biotechnology
ClinicalTrials.gov Identifier: NCT00485303
  Purpose

To evaluate anti-tumor effects and safety of CB7630 in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Drug: Abiraterone acetate (CB7630)
Drug: Prednisone
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Prednisone Docetaxel Abiraterone CB 7630
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

Further study details as provided by Cougar Biotechnology:

Primary Outcome Measures:
  • PSA response [ Time Frame: During Study Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
abiraterone acetate and prednisone
Drug: Abiraterone acetate (CB7630)
1000mg PO daily
Drug: Prednisone
5mg PO BID

Detailed Description:

In order to fully assess the efficacy of abiraterone acetate (CB7630) in patients who have been treated with docetaxel-based chemotherapy, this study is designed to assess anti-tumor activity of CB7630 given with prednisone in prostate cancer patients who have progressive disease after docetaxel-based chemotherapy.

  Eligibility

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

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Written Authorization for Use and Release of Health and Research Study Information (USA sites only) or Data Protection Consent (European sites only)has been obtained
  • Age ≥ 18 years and male
  • Histologically or cytologically confirmed adenocarcinoma of the prostate, but not with neuroendocrine differentiation or of small cell histology
  • Prior chemotherapy for prostate cancer with regimen(s) containing docetaxel.
  • Patients may have had up to two previous chemotherapy regimens.
  • Documented PSA progression according to PSAWG eligibility criteria with a PSA > 5 ng/mL
  • On-going androgen deprivation with serum testosterone < 50 ng/dL (< 2.0nM/L)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. (Karnofsky Performance Status ≥ 50%)
  • Any acute toxicities of prior chemotherapy, radiotherapy have resolved to a NCI CTCAE (version 3) grade of ≤ 1. Chemotherapy induced alopecia and grade 2 neuropathy are excluded from this consideration.
  • Life expectancy > 12 weeks
  • Able to swallow CB7630 whole as a tablet
  • Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements

Exclusion Criteria:

  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy
  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Uncontrolled hypertension
  • Hemoglobin ≤ 9.0 g/dL without growth factor or transfusion support
  • Abnormal liver function tests consisting of any of the following:Serum bilirubin > 1.5 x ULN; ALT > 2.5 x ULN; AST > 2.5 x ULN
  • Serum creatinine > 2.0 x UNL or a calculated creatinine clearance < 50 mL/min
  • Serum potassium < 3.5 mmol/L
  • Clinically significant heart disease as evidenced by a myocardial infarction in the past twelve months, severe or unstable angina, or New York Heart Association(NYHA) Class III or IV heart disease. Patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least two years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable.
  • Abnormal electrocardiogram, including any finding which would interfere with assessment of intervals (patients with long QT syndrome, bundle branch blocks or hemiblocks are prohibited)
  • Malignancy within the previous 5-years other than basal cell or squamous cell carcinomas of skin with a >30% probability of recurrence within 12 months.
  • History of adrenal insufficiency or hyperaldosteronism
  • History of gastrointestinal disorders (medical disorders or extensive surgery)which may interfere with the absorption of the study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485303

Locations
United States, California
UCLA
Los Angeles, California, United States, 90024
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Maryland
John Hopkins
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Dana-Farber Cancer Institute
BOSTON, Massachusetts, United States, 02115
Masachussetts General Hospital Cancer Center
BOSTON, Massachusetts, United States, 02114
Beth Israel Hospital
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan-Kettering Cancer Center
NEW YORK, New York, United States, 10021
United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
Sponsors and Collaborators
Cougar Biotechnology
Investigators
Principal Investigator: Howard Scher, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: JS deBono, MD PhD Royal Marsden NHS Foundation Trust
  More Information

NATIONAL CANCER INSTITUTE  This link exits the ClinicalTrials.gov site
AMERICAN SOCIETY OF CLINICAL ONCOLOGY  This link exits the ClinicalTrials.gov site
COUGAR BIOTECHNOLOGY  This link exits the ClinicalTrials.gov site
PROSTATE CANCER  This link exits the ClinicalTrials.gov site
MEDLINE PLUS  This link exits the ClinicalTrials.gov site

Responsible Party: Cougar Biotechnology, Inc. ( Christopher Haqq, MD, PhD )
Study ID Numbers: COU-AA-004
Study First Received: June 8, 2007
Last Updated: August 5, 2008
ClinicalTrials.gov Identifier: NCT00485303  
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cougar Biotechnology:
Abiraterone acetate
Abiraterone
CB7630
HPRC
Prednisone
Hormone Refractory
Prostate Cancer
Docetaxel-based Chemotherapy failure

Study placed in the following topic categories:
Docetaxel
Prednisone
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009