Study on Galunisertib and Enzalutamide for Treating Advanced Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT02452008

This clinical trial is testing whether combining the drug Galunisertib with Enzalutamide can help slow down the progression of advanced prostate cancer that no longer responds to hormone therapy.

Patient Parameters

Program Overview

The main goal of this study is to see if using Galunisertib together with Enzalutamide can extend the time patients with advanced prostate cancer live without their disease getting worse, compared to using Enzalutamide alone.

Eligibility Criteria

Inclusion Criteria

  • Have advanced prostate cancer that continues to grow despite hormone therapy.
  • Previously treated with the drug Abiraterone.
  • Expected to live more than 3 months.
  • Be in relatively good health, with a performance status score of 0 or 2.
  • Be 18 years or older.
  • Have cancer that can be measured by scans or tests.
  • Agree to have a tumor biopsy if it is safe to do so.
  • Be able to swallow pills.
  • Have good organ and bone marrow function based on specific lab tests.
  • Agree to use effective birth control during the study.
  • Understand and agree to sign a consent form to participate.

Exclusion Criteria

  • Have a history of cancer spreading to the brain.
  • Have received chemotherapy for advanced prostate cancer.
  • Had surgery within 4 weeks before starting the study treatment.
  • Had radiation or other cancer treatments within 2 weeks before starting the study treatment.
  • Used certain hormone therapies within 2 weeks before starting the study treatment.
  • Used systemic steroids within 1 week before starting the study treatment.
  • Previously treated with Enzalutamide, ARN-509, or Galeterone.
  • Have moderate or severe heart disease.
  • Have a history of seizures.
  • Have uncontrolled health issues, such as active infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that could affect participation.
  • Have a history of autoimmune diseases like inflammatory bowel disease, rheumatoid arthritis, or lupus.
  • Have a known infection with HIV, hepatitis B, or hepatitis C.

Locations

FACILITYZIPCITYSTATE
Sibley Memorial Hospital20016Washington D.C.District of Columbia
Northwestern University60611ChicagoIllinois
University of Chicago60637ChicagoIllinois
Johns Hopkins University21205BaltimoreMaryland

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