A QT/QTc and Multi-dose Pharmacokinetic (PK) Study of Abiraterone Acetate - Full Text View

Sponsor:	Cougar Biotechnology, Inc.
Information provided by:	Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT00910754

Purpose

This is a phase 1B study to determine the effect of abiraterone acetate and prednisone on the conduction of electricity in the heart and the blood levels of abiraterone acetate and abiraterone in the body over a period of time.

Condition	Intervention	Phase
Metastatic Castration-Resistant Prostate Cancer	Drug: abiraterone acetate plus prednisone	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone CB 7630 Abiraterone

U.S. FDA Resources

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

Primary Outcome Measures:

The primary objective of this study is to evaluate the effects of abiraterone acetate plus prednisone on cardiac QT/QTc interval by using pharmacokinetic and time-matched ECGs in patients with metastatic castration-resistant prostate cancer (CRPC). [ Time Frame: Cardiac QT/QTc interval measurements will be collected at selected time points in the first 2 cycles of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the PK of abiraterone acetate and abiraterone. [ Time Frame: Abiraterone and abiraterone acetate PK measurements will be collected at selected time points in the first 2 cycles of the study ] [ Designated as safety issue: No ]
To evaluate the effects of abiraterone acetate and prednisone on adrenal function [ Time Frame: Adrenal function assessment will be measured before treatment and after treatment discontinuation ] [ Designated as safety issue: No ]
To evaluate the anti-tumor effects of abiraterone acetate and prednisone [ Time Frame: Efficacy assessment will be done every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 abiraterone acetate plus prednisone	Drug: abiraterone acetate plus prednisone abiraterone acetate 1000 mg daily (QD) as 4 x 250-mg tablets and prednisone 5 mg orally twice a day (BID).

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
No chemotherapy/biologic therapy or no more than 1 line of prior chemotherapy/biologic therapy
Progression after previous prostate cancer therapy
ECOG performance status of either 0 or 1
Medical or surgical castration with testosterone of less than 50ng/dL
Able to provide informed consent

Exclusion Criteria:

Prior chemotherapy with mitoxantrone or anthracyclines
Known brain metastasis
Clinically significant heart disease
Diagnosis of arrhythmia requiring therapy
Abnormal electrocardiogram

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910754

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Canada, British Columbia
BC Cancer Agency-Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6

Sponsors and Collaborators

Cougar Biotechnology, Inc.

More Information

Additional Information:

COUGAR BIOTECHNOLOGY, INC. 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

NATIONAL INSTITUTE OF HEALTH This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NamPhuong Tran, MD, Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT00910754 History of Changes
Other Study ID Numbers:	COU-AA-006
Study First Received:	May 28, 2009
Last Updated:	February 15, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Cougar Biotechnology, Inc.:

Metastatic Castration Resistant Prostate Cancer
CRPC
Abiraterone Acetate
CB7630

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012