Description:
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).
Title
- Brief Title: Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
J1557
- SECONDARY ID:
IRB00065746
- NCT ID:
NCT02452008
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Enzalutamide | XTANDI | Arm 1: Enzalutamide with LY2157299 |
LY2157299 | TGF-β receptor inhibitor | Arm 1: Enzalutamide with LY2157299 |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1: Enzalutamide with LY2157299 | Experimental | | |
Arm 2: Enzalutamide alone | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Have metastatic castration-resistant prostate cancer
- Must have had prior abiraterone treatment
- Life expectancy of greater than 3 months
- 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
- Ability to understand and willingness to sign a written informed consent document
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
- Have a history of any autoimmune disease:inflammatory bowel disease, (including
ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive
sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis
(e.g., Wegener's Granulomatosis), CNS or motor neuropathy considered to be of
autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple
Sclerosis)
- Have known history of infection with HIV, hepatitis B, or hepatitis C
Maximum Eligible Age: | 100 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Number of patients experiencing treatment-related toxicities |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Trial Keywords
- metastatic castration-resistant prostate cancer
- enzalutamide
- LY2157299
- TGF-β receptor inhibitor
Last Updated
April 12, 2021