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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hormone Refractory Prostate Cancer; Prostate Cancer

Treatments: Drug: MDV3100

Study type: Interventional

Funder types: Industry

Identifiers

NCT00510718

C3431009 (Other Identifier)

S-3100-1-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Male

Volunteers: No Healthy Volunteers

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);

Trial design

140 participants in 1 patient group

1

Experimental group

Description:

MDV3100

Treatment:

Drug: MDV3100