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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02452008
Recruitment Status : Recruiting
First Posted : May 22, 2015
Last Update Posted : June 6, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE May 20, 2015
First Posted Date  ICMJE May 22, 2015
Last Update Posted Date June 6, 2023
Actual Study Start Date  ICMJE May 3, 2016
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)		 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. [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
  • Tumor marker kinetics (PSA) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2). [ Time Frame: 4 years ]
  • Overall survival (OS) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2). [ Time Frame: 4 years ]
  • Number of patients experiencing treatment-related toxicities [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
    Other Name: XTANDI
  • Drug: LY2157299
    150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle.
    Other Name: TGF-β receptor inhibitor
Study Arms  ICMJE
  • Experimental: Arm 1: Enzalutamide with LY2157299
    Interventions:
    • Drug: Enzalutamide
    • Drug: LY2157299
  • Experimental: Arm 2: Enzalutamide alone
    Intervention: Drug: Enzalutamide
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Irina Rifkind, RN 410-502-2043 irifkin1@jhmi.edu
Contact: Channing Paller, MD 410-955-8239 cpaller1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02452008
Other Study ID Numbers  ICMJE J1557
IRB00065746 ( Other Identifier: JHMIRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Channing Paller, MD Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date June 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP