Clinical Trials /

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

NCT02452008

Description:

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).

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: J1557
  • SECONDARY ID: IRB00065746
  • NCT ID: NCT02452008

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
EnzalutamideXTANDIArm 1: Enzalutamide with LY2157299
LY2157299TGF-β receptor inhibitorArm 1: Enzalutamide with LY2157299

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Arm 1: Enzalutamide with LY2157299Experimental
  • Enzalutamide
  • LY2157299
Arm 2: Enzalutamide aloneExperimental
  • Enzalutamide

Eligibility Criteria

        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
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Number of patients experiencing treatment-related toxicities
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • metastatic castration-resistant prostate cancer
  • enzalutamide
  • LY2157299
  • TGF-β receptor inhibitor

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