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

Johns Hopkins Medicine

Status and phase

Active, not recruiting

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: LY2157299

Drug: Enzalutamide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02452008

IRB00065746 (Other Identifier)

J1557

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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