Overcoming Drug Resistance in Metastatic Castration-resistant Prostate Cancer With Novel Combination of TGF-β Receptor Inhibitor LY2157299 and Enzalutamide: a Randomized Multi-site Phase II Study

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4 sites in 1 country60 target enrollmentMay 3, 2016

ConditionsProstate Cancer

InterventionsEnzalutamide LY2157299

DrugsEnzalutamide LY2157299

Overview

Phase: Phase 2
Intervention: Enzalutamide
Conditions: Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 60
Locations: 4
Primary Endpoint: 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.
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 3, 2016

End Date

December 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have metastatic castration-resistant prostate cancer
•Must have had prior abiraterone treatment
•Life expectancy of greater than 3 months
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
•Age ≥18 years
•Have measurable disease
•Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
•Ability to take oral medication
•Patients must have adequate organ and marrow function defined by study-specified laboratory tests
•Must use acceptable form of birth control while on study

Exclusion Criteria

•Known history or evidence of brain metastases
•Prior chemotherapy for metastatic disease in castration-resistant prostate cancer
•Had surgery within 4 weeks prior to the first dose of study drug
•Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug
•Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug
•Systemic steroids within 1 weeks prior to the first dose of study drug
•Had prior enzalutamide, ARN-509, or galeterone therapy
•Have moderate or severe cardiovascular disease
•Have a history of a seizure
•Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements

Arms & Interventions

Arm 1: Enzalutamide with LY2157299

Intervention: Enzalutamide

Arm 1: Enzalutamide with LY2157299

Intervention: LY2157299

Arm 2: Enzalutamide alone

Intervention: Enzalutamide

Outcomes

Primary Outcomes

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

Secondary Outcomes

Number of patients experiencing treatment-related toxicities(4 years)
Tumor marker kinetics (PSA) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).(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).(4 years)