Clinical Trial: Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
Brief Summary: The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
Detailed Summary:
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome: Progression free survival in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2) using RECIST 1.1 criteria. [ Time Frame: 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Tumor marker kinetics (PSA) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2). [ Time Frame: 4 years ]
- Overall survival (OS) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2). [ Time Frame: 4 years ]
- Number of patients experiencing treatment-related toxicities [ Time Frame: 4 years ]
Original Secondary Outcome: Same as current
Information By: Sidney Kimmel Comprehensive Cancer Center
Dates:
Date Received: May 20, 2015
Date Started: April 2016
Date Completion:
Last Updated: August 22, 2016
Last Verified: August 2016
