Prostate Cancer Clinical Trial

Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer

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).

View Eligibility Criteria

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
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), central nervous system (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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT02452008

Recruitment Status:

Active, not recruiting

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There are 4 Locations for this study

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Sibley Memorial Hospital
Washington District of Columbia, 20016, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Johns Hopkins University
Baltimore Maryland, 21205, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT02452008

Recruitment Status:

Active, not recruiting

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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