Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT02452008
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2016-05-03
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Enzalutamide with LY2157299
Enzalutamide
160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
LY2157299
150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle.
Arm 2: Enzalutamide alone
Enzalutamide
160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
Interventions
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Enzalutamide
160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
LY2157299
150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
MALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
National Capital Foundation
UNKNOWN
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Channing Paller, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Countries
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References
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Rodriguez Y, Unno K, Truica MI, Chalmers ZR, Yoo YA, Vatapalli R, Sagar V, Yu J, Lysy B, Hussain M, Han H, Abdulkadir SA. A Genome-Wide CRISPR Activation Screen Identifies PRRX2 as a Regulator of Enzalutamide Resistance in Prostate Cancer. Cancer Res. 2022 Jun 6;82(11):2110-2123. doi: 10.1158/0008-5472.CAN-21-3565.
Other Identifiers
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IRB00065746
Identifier Type: OTHER
Identifier Source: secondary_id
J1557
Identifier Type: -
Identifier Source: org_study_id