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A Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Hormone Refractory Prostate Cancer

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Trial Information

A Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer


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.


Inclusion Criteria:



1. Histologically or cytologically confirmed adenocarcinoma of the prostate;

2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH)
analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);

3. 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);

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Howard Scher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

S-3100-1-01

NCT ID:

NCT00510718

Start Date:

June 2007

Completion Date:

July 2012

Related Keywords:

  • Prostate Cancer
  • Hormone Refractory Prostate Cancer
  • Prostate
  • Cancer
  • Hormone
  • Refractory
  • Castration
  • Prostatic Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of WashingtonSeattle, Washington  98195
Oregon Health and Science UniversityPortland, Oregon  97201