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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:2/13/2019
Start Date:April 2016
End Date:July 2021
Contact:Irina Rifkind, RN
Email:irifkin1@jhmi.edu
Phone:410-502-2043

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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

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).


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
We found this trial at
4
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Channing Paller, MD
Phone: 410-614-6321
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Russel Szmulewitz, MD
Phone: 773-702-7609
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Maha Hussain, MD
Phone: 312-908-5487
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5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Principal Investigator: Channing Paller, MD
Phone: 202-660-5772
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
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