A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer - Full Text View

Sponsor:	Medivation, Inc.
Information provided by:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00510718

Purpose

This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

Condition	Intervention	Phase
Prostate Cancer Hormone Refractory Prostate Cancer	Drug: MDV3100	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:

Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics, PSA response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MDV3100	Drug: MDV3100 MDV3100 daily until progression or dose-limiting toxicity

Detailed Description:

This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate;
Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
Progressive disease after medical or surgical castration,

Exclusion Criteria:

1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510718

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York City, New York, United States, 10021
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98502

Sponsors and Collaborators

Medivation, Inc.

Investigators

Principal Investigator:

Howard Scher, MD

Memorial Sloan-Kettering Cancer Center

More Information

No publications provided

Responsible Party:	Medivation, Inc. ( Mohammad Hirmand, MD )
Study ID Numbers:	S-3100-1-01
Study First Received:	July 31, 2007
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00510718 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:

Prostate
Cancer
Hormone
Refractory
Castration

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009