Galunisertib + Enzalutamide for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but you must not have had certain cancer therapies or systemic steroids shortly before starting the trial.
Is the combination of Galunisertib and Enzalutamide safe for humans?
How is the drug combination of Galunisertib and Enzalutamide unique for treating prostate cancer?
The combination of Galunisertib and Enzalutamide is unique because it pairs Enzalutamide, an oral drug that blocks male hormones from stimulating cancer growth, with Galunisertib, which may have different mechanisms of action, potentially offering a novel approach to treating prostate cancer compared to using Enzalutamide alone.24678
Who Is on the Research Team?
Channing Paller, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
Men over 18 with metastatic castration-resistant prostate cancer who've had abiraterone treatment and can take pills. They need to be well enough for daily activities, have a life expectancy over 3 months, and agree to birth control use. Excluded are those with recent surgery, certain heart diseases, seizures, brain metastases, prior specific treatments for this cancer stage or autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enzalutamide in combination with LY2157299 or enzalutamide alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enzalutamide
- LY2157299
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
National Capital Foundation
Collaborator
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University