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 trial is active, not recruiting.
|Condition||castration-resistant prostate cancer (crpc)|
|Sponsor||Astellas Pharma Inc|
|Start date||November 2011|
|End date||April 2017|
|Trial size||52 participants|
|Trial identifier||NCT01534052, 9785-CL-0121|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Aurora, CO||Site US107 University of Colorado||no longer recruiting|
|Chicago, IL||Site US104 University of Chicago||no longer recruiting|
|Pittsburgh, PA||Site US105 University of Pittsburgh Medical Center||no longer recruiting|
|San Antonio, TX||Site US106 South Texas Oncology & Hematology||no longer recruiting|
|Chisinau, Moldova, Republic of||Site MD37301 Arensia Exploratory Medicine||no longer recruiting|
|George, South Africa||Site ZA2701 Private Practice||no longer recruiting|
|Port Elizabeth, South Africa||Site ZA2702 Phoenix Pharma||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
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)
Male participants at least 18 years old.
- 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
- 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.
|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|
|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.|
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