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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 3, 2022
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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 disease Intervention/treatment Phase
Prostate Cancer Drug: Enzalutamide Drug: LY2157299 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 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
Experimental: Arm 2: Enzalutamide alone Drug: Enzalutamide
160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
Other Name: XTANDI


Outcome Measures
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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. [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 4 years ]
  3. Number of patients experiencing treatment-related toxicities [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452008


Contacts
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Contact: Irina Rifkind, RN 410-502-2043 irifkin1@jhmi.edu
Contact: Channing Paller, MD 410-955-8239 cpaller1@jhmi.edu

Locations
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United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Janice Powers, RN    202-660-5772    jpower22@JHMI.EDU   
Principal Investigator: Channing Paller, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Maha Hussain, MD    312-908-5487    maha.hussain@northwestern.edu   
Principal Investigator: Maha Hussain, MD         
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Channing Paller, MD    410-614-6321    cpaller@JHMI.EDU   
Contact: Irina Rifkind, RN    410-502-2043    irifkin1@JHMI.EDU   
Principal Investigator: Channing Paller, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eli Lilly and Company
Investigators
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Principal Investigator: Channing Paller, MD Johns Hopkins University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02452008    
Other Study ID Numbers: J1557
IRB00065746 ( Other Identifier: JHMIRB )
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: January 2022
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
metastatic castration-resistant prostate cancer
enzalutamide
LY2157299
TGF-β receptor inhibitor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases