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

NCT01534052 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 9785-CL-0121
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

Conditions

Castration-Resistant Prostate Cancer (CRPC)

Keywords

Prostate Cancer; Castration-Resistant Prostate Cancer (CRPC); MDV3100; Androgen receptor signaling inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.

  From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days

Study Arms (1)

Enzalutamide

EXPERIMENTAL

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.

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

Oral

Also known as: MDV3100, ASP9785, Xtandi

Enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male subjects and their female spouses/partners who are of childbearing potential must be using highly effective contraception1 consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 3 months after final study drug administration. Male subjects must not donate sperm starting at Screening and throughout the study period and for at least 3 months after final study drug administration. 1Highly effective contraception is defined as:
• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal form/gel/film/ cream/suppository
• Subject agrees not to participate in another interventional study while on treatment

You may not qualify if:

• Subject will be excluded from participation if any of the following apply:
• Subject has a history of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumours, brain metastases, or alcoholism.
• Subject has a history of loss of consciousness or transient ischemic attack within 12 months prior to Day 1 of the completed preceding study.
• Use of the following prohibited medication/therapies:
• Concomitant medication that likely could cause clinically relevant drug-to-drug interactions with MDV3100.
• Other (than MDV3100) androgen-receptor (AR) antagonists (bicalutamide, flutamide, nilutamide).
• Investigational therapy other than MDV3100 or investigational procedures of any kind.

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Medivation LLC, a wholly owned subsidiary of Pfizer Inc.: collaborator

Study Sites (7)

Site US107

Aurora, Colorado, 80045, United States

Location

Site US104

Chicago, Illinois, 60637, United States

Location

Site US105

Pittsburgh, Pennsylvania, 15215, United States

Location

Site US106

San Antonio, Texas, 78253, United States

Location

Site MD37301

Chisinau, Moldova

Location

Site ZA2701

George, 6529, South Africa

Location

Site ZA2702

Port Elizabeth, 6001, South Africa

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma Europe B.V. (APEB)

astellas.resultsdisclosure@astellas.com

800-888-7704 Ext:5473

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 16, 2012
• Study Start: October 21, 2011
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: December 6, 2024
• Results First Posted: April 27, 2018

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); ZA (2); MO (1)