TAK-700 in Castration Resistant Prostate Cancer
- Registration Number
- NCT01658527
- Brief Summary
The objective of this randomized phase II open label trial is to determine the anti-tumor activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH (luteinizing hormone-releasing hormone) agonists or surgical castration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bicalutamide 50 mg per day Bicalutamide - Orteronel, 300 mg twice daily Orteronel -
- Primary Outcome Measures
Name Time Method The primary endpoint of the trial is clinical progression free survival. The primary endpoint of the trial is clinical progression free survival. In this protocol, it is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group 2" and referred to as the "PCWG2" for the setting "delay/prevent" progression.
- Secondary Outcome Measures
Name Time Method RECIST (Response Evaluation Criteria In Solid Tumors) response in patients presenting with measurable disease Time to PSA (Prostate specific antigen) progression and PSA change from baseline Overall survival Safety according to Common Terminology Criteria for Adverse Events, version 4.03 Pain (when an SAE (Serious Adverse Event)) or pain requiring initiation of narcotic analgesia Skeletal related events, including requirement to initiate chemotherapy, radiotherapy, cord compression or requirement for surgery to the bone
Trial Locations
- Locations (4)
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aals, Belgium
AZ Groeninge Kortrijk - Campus Vercruysselaan
🇧🇪Kortrijck, Belgium
CHU Dinant Godinne - UCL Namur
🇧🇪Yvoir, Belgium