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Pharmacokinetic Study of Abiraterone Acetate Tablets and Capsules Followed by Safety and Efficacy Evaluation of Continuous Tablet Dosing
This study is ongoing, but not recruiting participants.
First Received: January 14, 2008   Last Updated: January 22, 2009   History of Changes
Sponsor: Cougar Biotechnology, Inc.
Information provided by: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00600535
  Purpose

To compare the total exposure of CB7630 administered in capsule formulation with that in tablet formulation in patients with prostate cancer under fasted and fed conditions


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

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title: A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients With Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and efficacy of continuous dosing [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: July 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (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

  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, cytologically, or biochemically confirmed adenocarcinoma of the prostate
  • Serum potassium ≥ 3.5 mmol/L
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2 (Karnofsky Performance Status ≥ 50%)
  • 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.
  • No radiotherapy, chemotherapy or immunotherapy within 30 days of administration of the SD1 on 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 SD1 on Day 1.
  • Life expectancy > 12 weeks
  • Able to swallow the CB7630 whole as a capsule or 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
  • 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 ULN or a calculated 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 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: NCT00600535

Locations
United States, California
UCLA
Los Angeles, California, United States, 90024
United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
Beatson Oncology Centre
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
Cougar Biotechnology, Inc.
Investigators
Principal Investigator: JS de Bono, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Cougar Biotechnology ( Thomas Griffin, MD )
Study ID Numbers: COU-AA-BE
Study First Received: January 14, 2008
Last Updated: January 22, 2009
ClinicalTrials.gov Identifier: NCT00600535     History of Changes
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cougar Biotechnology, Inc.:
Abiraterone Acetate
CB7630
Prostate Cancer

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

ClinicalTrials.gov processed this record on November 27, 2009