Back to resultsA Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
Primary Purpose
Castration-Resistant Prostate Cancer (CRPC)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Enzalutamide
Sponsored by
About this trial
This is an interventional treatment trial for Castration-Resistant Prostate Cancer (CRPC) focused on measuring Prostate Cancer, Castration-Resistant Prostate Cancer (CRPC), MDV3100, Androgen receptor signaling inhibitor
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
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:
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.
Sites / Locations
- Site US107
- Site US104
- Site US105
- Site US106
- Site MD37301
- Site ZA2701
- Site ZA2702
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enzalutamide
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01534052
First Posted
February 8, 2012
Last Updated
September 7, 2018
Sponsor
Astellas Pharma Inc
Collaborators
Medivation, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01534052
Brief Title
A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 21, 2011 (Actual)
Primary Completion Date
April 18, 2017 (Actual)
Study Completion Date
April 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Medivation, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This was a multi-center extension study in participants 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 participant. For the study duration, all participants with castration-resistant prostate cancer (CRPC) maintained androgen deprivation with a Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonist unless they underwent bilateral orchiectomy. Participants were discontinued from study drug when the continued administration of study drug was deemed to be not in the participants' best interest by the investigator based on clinical assessment. Throughout the study, safety and tolerability were assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Participants had a safety follow-up visit 30 days after their last dose of study drug. Participants that did not meet any of the discontinuation criteria were eligible to continue to receive treatment with enzalutamide in study 9785-CL-0123 [NCT02960022] upon approval and activation of the study at the participating institution. Participants who enrolled in study 9785-CL-0123 [NCT02960022] were not required to have a safety follow-up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-Resistant Prostate Cancer (CRPC)
Keywords
Prostate Cancer, Castration-Resistant Prostate Cancer (CRPC), MDV3100, Androgen receptor signaling inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enzalutamide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
MDV3100, ASP9785, Xtandi
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Manager
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
Facility Name
Site US107
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Site US104
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Site US105
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
Site US106
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78253
Country
United States
Facility Name
Site MD37301
City
Chisinau
Country
Moldova, Republic of
Facility Name
Site ZA2701
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Site ZA2702
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=241
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
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