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

Sponsor:	Cougar Biotechnology, Inc.
Information provided by:	Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT01017939

Purpose

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

Condition	Intervention	Phase
Metastatic Castration-Resistant Prostate Cancer	Drug: dextromethorphan hydrobromide or theophylline	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Drug Reactions Prostate Cancer

Drug Information available for: Prednisone Theophylline Dextromethorphan hydrochloride CB 7630 Abiraterone Levomethorphan Dextromethorphan Racemethorphan Dextromethorphan hydrobromide Theophylline sodium glycinate

U.S. FDA Resources

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

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	37
Study Start Date:	January 2010
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
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.	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.

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
Progression after previous prostate cancer therapy
ECOG performance status of ≤ 2
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
Able to provide informed consent

Exclusion Criteria:

Known brain metastasis
Clinically significant heart disease
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017939

Locations

United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
United States, Texas
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6

Sponsors and Collaborators

Cougar Biotechnology, Inc.

More Information

Additional 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

No publications provided

Responsible Party:	Namphuong Tran MD, Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT01017939 History of Changes
Other Study ID Numbers:	COU-AA-015
Study First Received:	November 19, 2009
Last Updated:	August 23, 2010
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Cougar Biotechnology, Inc.:

Metastatic Castration-Resistant Prostate Cancer
abiraterone acetate
CB7630

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dextromethorphan
Theophylline
Prednisone
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012