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A Phase II Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Failed Taxane-Based Chemotherapy
This study is ongoing, but not recruiting participants.
Sponsored by: Cougar Biotechnology
Information provided by: Cougar Biotechnology
ClinicalTrials.gov Identifier: NCT00474383
  Purpose

To evaluate the anti-tumor effects of CB7630 in patients with androgen independent metastatic prostate cancer (AIPC) who have failed docetaxel based chemotherapy, as measured by the proportion of patients achieving a PSA decline of >50% (PSA response) according to Prostate-Specific Antigen Working Group (PSAWG) criteria


Condition Intervention Phase
Prostate Cancer
Drug: Abiraterone Acetate
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Docetaxel Abiraterone CB 7630
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Open Label Study of CB7630 (Abiraterone Acetate) 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:
  • Anti-tumor effects [ Time Frame: Disease progression ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Duration of Study ]

Estimated Enrollment: 33
Study Start Date: December 2006
Estimated Study Completion Date: June 2008
Detailed Description:

Castrated male patients with androgen independent metastatic prostate cancer who have failed taxane based chemotherapy.

  Eligibility

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

Inclusion Criteria:

  • Patients must be/have the following for entry into the study:
  • 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 paclitaxel or docetaxel
  • Documented PSA progression according to PSAWG eligibility criteria (Appendix 1) with a PSA > 20 ng/mL
  • On-going androgen deprivation with serum testosterone < 50 ng/dL (< 2.0nM/L)
  • Serum potassium ≥ 3.5 mmol/L
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. (Karnofsky Performance Status ≥ 50%) (Appendix 4)
  • No history of adrenal insufficiency or hyperaldosteronism
  • 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. (Appendix 3)
  • No radiotherapy, chemotherapy or immunotherapy within 30 days of administration of the Cycle 1 Day 1
  • No surgery or local prostatic intervention within 28 days of the first dose. In addition, any clinically relevant sequelae from the surgery must have resolved prior to Cycle 1 Day 1.
  • Life expectancy > 12 weeks
  • Able to swallow the CB7630 whole as a tablets
  • Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements

Exclusion Criteria:

  • The following are criteria for exclusion from participating in the study:
  • 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
  • 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 calculate creatinine clearance < 50 mL/min
  • 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.
  • Other 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 gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1
  • Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474383

Locations
United States, California
Ucsf Comprehensive Cancer Center
SAN FRANCISCO, California, United States, 94143
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: Johann Sebastian de Bono, MD Royal Marsden NHS Foundation Trust
Principal Investigator: Howard Scher, MD Memorial Sloan-Kettering Cancer Center
  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
PROSTATE CANCER  This link exits the ClinicalTrials.gov site
MEDLINE PLUS  This link exits the ClinicalTrials.gov site

Study ID Numbers: COU-AA-003
Study First Received: May 14, 2007
Last Updated: January 14, 2008
ClinicalTrials.gov Identifier: NCT00474383  
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cougar Biotechnology:
Post-chemo failed hormone resistant
CB7630
Abiraterone Acetate

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009