Abiraterone Acetate Plus Prednisone Drug-Drug Interaction With Dextromethorphan and Theophylline Treating Metastatic Castration-Resistant Prostate Cancer

Verified by: Cougar Biotechnology, Inc., August 2010
First Received: November 19, 2009 | Last Updated: August 23, 2010 | Phase: Phase 1 | Start Date: January 2010
Overall Status: Active, not recruiting | Estimated Enrollment: 37
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This is a multicenter, open label drug-drug interaction study of abiraterone acetate and prednisone in patients with metastatic CRPC...

Brief Summary

Official Title: “An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer”

This is a multicenter, open label drug-drug interaction study of abiraterone acetate and prednisone in patients with metastatic CRPC.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
  • Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

  • Drug: dextromethorphan hydrobromide or theophylline
    • Group A - Dextromethorphan Hydrobromide, 30 mg capsule (2 x 15mg) given orally as a single dose. Group B - Theophylline, 100 mg tablet given orally as a single dose.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Group A
    • Group A will assess the effect of multiple doses of abiraterone acetate plus prednisone on CYP2D6 using dextromethorphan hydrobromide (HBr) as a probe drug.
  • Experimental: Group B
    • Group B will assess the effect of multiple doses of abiraterone acetate plus prednisone on CYP1A2 using theophylline as a probe drug.

Outcome Measures for this Clinical Trial

Primary Measures

  • To evaluate the effects of multiple doses of abiraterone acetate plus prednisone on the pharmacokinetics of a single dose of dextromethorphan hydrobromide (HBr) in patients with metastatic castration-resistant prostate cancer (CRPC).
    • Time Frame: During the Study
      Safety Issue?: Yes

Secondary Measures

  • To evaluate the effects of multiple doses of abiraterone acetate plus prednisone on the pharmacokinetics of a single dose of theophylline in patients with metastatic castration-resistant prostate cancer (CRPC).
    • Time Frame: During the study
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 1. Metastatic castration resistant prostate cancer
  • 2. Progression after previous prostate cancer therapy
  • 3. ECOG performance status of ≤ 2
  • 4. Approximately the first 20 patients entering the study will be asked to complete a genomic testing for an enzyme CYP2D6 activity using a buccal swab to determine if the patients will be part of Group A or Group B
  • 5. Able to provide informed consent

Exclusion Criteria:

  • 1. Known brain metastasis
  • 2. Clinically significant heart disease
  • 3. For Group A - Prior treatment with dextromethorphan or dextromethorphan-containing product or strong inducers or inhibitors of CYP2D6 within 5 half-lives of that drug or 7 days, whichever is longer, prior to Cycle 1 Day -8
  • 4. For Group B - Prior treatment with theophylline or strong inducers or inhibitors of CYP1A2 within 5 half-lives of that drug or 7 days, whichever is longer, prior to Cycle 1 Day -8

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Cougar Biotechnology, Inc. Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01017939

Study ID Number: COU-AA-015

ClinicalTrials.gov Identifier: NCT01017939

Health Authority: United States: Food and Drug Administration

(COUGAR BIOTECHNOLOGY)

(AMERICAN SOCIETY OF CLINICAL ONCOLOGY)

(NATIONAL CANCER INSTITUTE)

(PROSTATE CANCER)

(MEDLINE PLUS)

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01017939