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

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Recruiting
CT.gov ID
NCT02452008
Collaborator
Eli Lilly and Company (Industry)
60
Enrollment
4
Locations
2
Arms
78.9
Anticipated Duration (Months)
15
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 3, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm 1: Enzalutamide with LY2157299

Drug: Enzalutamide
160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
Other Names:
  • XTANDI
  • Drug: LY2157299
    150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle.
    Other Names:
  • TGF-β receptor inhibitor
  • Experimental: Arm 2: Enzalutamide alone

    Drug: Enzalutamide
    160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
    Other Names:
  • XTANDI
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [4 years]

    Secondary Outcome Measures

    1. Tumor marker kinetics (PSA) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2). [4 years]

    2. Overall survival (OS) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2). [4 years]

    3. Number of patients experiencing treatment-related toxicities [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Sibley Memorial HospitalWashingtonDistrict of ColumbiaUnited States20016
    2Northwestern UniversityChicagoIllinoisUnited States60611
    3University of ChicagoChicagoIllinoisUnited States60637
    4Johns Hopkins UniversityBaltimoreMarylandUnited States21205

    Sponsors and Collaborators

    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Eli Lilly and Company

    Investigators

    • Principal Investigator: Channing Paller, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT02452008
    Other Study ID Numbers:
    • J1557
    • IRB00065746
    First Posted:
    May 22, 2015
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 1, 2021