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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01534052
First received: February 8, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Castration-Resistant Prostate Cancer (CRPC)
Drug: MDV3100
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Extension Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Long term safety of continued administration of MDV3100 through assessment of adverse events, vital signs, ECGs, physical examinations and laboratory evaluations [ Time Frame: Until Subject Discontinuation (up to 5 years) ] [ Designated as safety issue: No ]
    Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Subjects will have a safety follow-up visit 30 days after their last dose of study drug.


Enrollment: 52
Study Start Date: November 2011
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100 Drug: MDV3100
Oral
Other Name: ASP9785

Detailed Description:

This is a multi-center extension study in subjects with prostate cancer who have completed MDV3100 treatment study to assess the long-term safety of continued administration of MDV3100, when judged by the investigator to be in the best interest of the subject.

For the study duration, all subjects with castration-resistant prostate cancer (CRPC) will have to maintain androgen deprivation with a Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonist unless they underwent bilateral orchiectomy.

Subjects will be discontinued from study drug when continued administration of study drug is deemed to be not in the subject's best interest by the investigator based on clinical assessment.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs).

Subjects will have a safety follow-up visit 30 days after their last dose of study drug.

  Eligibility

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534052

Locations
United States, Colorado
Site: 107
Aurora, Colorado, United States, 80045
United States, Illinois
Site: 104
Chicago, Illinois, United States, 60637
United States, Pennsylvania
Site: 105
Pittsburgh, Pennsylvania, United States, 15215
United States, Texas
Site: 106
San Antonio, Texas, United States, 78253
Moldova, Republic of
Site: 37301
Chisinau, Moldova, Republic of
South Africa
Site: 2701
George, South Africa, 6529
Site: 2702
Port Elizabeth, South Africa, 6045
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01534052     History of Changes
Other Study ID Numbers: 9785-CL-0121
Study First Received: February 8, 2012
Last Updated: June 30, 2014
Health Authority: Moldova: Ministry of Health
South Africa: Medicines Control Council
United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Prostate Cancer
Castration-Resistant Prostate Cancer (CRPC)
MDV3100
Androgen receptor signaling inhibitor

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014