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

June 5, 2023 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Channing Paller, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Maha Hussain, MD
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Channing Paller, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
4 years
Number of patients experiencing treatment-related toxicities
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Eli Lilly and Company

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2016

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimated)

May 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1557
  • IRB00065746 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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