A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Astellas Pharma Inc

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

A study to assess the safety of continued administration of MDV3100 in subjects with Prostate Cancer who have already undergone treatment with MDV3100 and showed benefit.

Research Team

Clinical Study Manager

Principal Investigator

Astellas Pharma Europe B.V.

Eligibility Criteria

Inclusion Criteria

Has completed a prior study with MDV3100, can be enrolled in this extension study without any interruption in study drug

No new clinically significant abnormalities based upon physical examination, safety laboratory data, vital signs, ECG, and other clinical assessments noted from the last visit conducted during the subject's active MDV3100 study prior to initiation of this study

Subject agrees not to participate in another interventional study while on treatment

See 3 more

Treatment Details

Interventions

Enzalutamide (Anti-androgen)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: EnzalutamideExperimental Treatment1 Intervention

Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.

Enzalutamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Xtandi for:

Metastatic castration-resistant prostate cancer (mCRPC)
Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in Japan as Xtandi for:

Metastatic castration-resistant prostate cancer (mCRPC)
Non-metastatic castration-resistant prostate cancer (nmCRPC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Astellas Pharma Inc

Lead Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

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