Spots Global Cancer Trial Database for CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
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Trial Identification
Brief Title: CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
Official Title: A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel in Subjects With Advanced Breast Cancer
Study ID: NCT02580448
Interventions
Study Description
Brief Summary: The goal of this clinical study is to determine the safety, pharmacokinetics, pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.
Detailed Description: This is an open-label, Phase 1/2 study of seviteronel in subjects with TNBC or ER +/HER2 normal unresectable locally advanced breast cancer. Only women will be enrolled in Phase 1 and both men and women enrolled into their respective cohorts in Phase 2. There will be a dose confirmation Phase 1 portion of the study to establish the recommended Phase 2 dose (RP2D) for women with breast cancer using a non-stratified, combined cohort of women with TNBC or ER+ BC. Cohort expansion will occur in Phase 2 at the RP2D confirmed/established in Phase 1 using separate TNBC and ER+ cohorts. The Phase 2 portion of the study is divided into three parallel cohorts: Cohort 1: Female TNBC Subjects Cohort 2: Female ER+ Subjects Cohort 3: Male ER+ BC or TNBC Subjects
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Wallace Tumor Institute- University of Alabama, Birmingham, Alabama, United States
Clearview Cancer Institute, Huntsville, Alabama, United States
University of Colorado, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Lakewood, Colorado, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists- North, Saint Petersburg, Florida, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
SCRI - HCA Midwest Division, Kansas City, Kansas, United States
University of Louisville Hospital / James Brown Cancer Center, Louisville, Kentucky, United States
Maryland Oncology Hematology, Silver Spring, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Masonic Cancer Center, Minneapolis, Minnesota, United States
Cancer Network/Oncology Associates PC, Omaha, Nebraska, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
Memorial Sloan Kettering, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center - Oncology Research, Charlotte, North Carolina, United States
Duke University, Durham, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Oncology Hematology Care, Inc, Cincinnati, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
Charleston Hematology and Oncology Associates, Charleston, South Carolina, United States
Precision Cancer Research/Brig Center for Cancer Care and Survivorship, LLC, Knoxville, Tennessee, United States
SCRI Tenessee Oncology Nashville, Nashville, Tennessee, United States
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
The Center for Cancer and Blood Disorders (Fort Worth), Fort Worth, Texas, United States
US Oncology, Fort Worth, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Contact Details
Name: Victoria Brown, BS
Affiliation: Sponsor GmbH
Role: STUDY_CHAIR
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