CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
- Conditions
- Cancer of the BreastBreast CancerMale Breast CancerAdvanced Breast CancerMetastatic Breast CancerTriple Negative Breast CancerER+ Breast Cancer
- Interventions
- Registration Number
- NCT02580448
- Lead Sponsor
- Innocrin Pharmaceutical
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Male Breast Cancer Patients Seviteronel Locally advanced or metastatic males with BC Female Triple Negative Breast Cancer Patients Seviteronel TNBC Patients - Enrollment is complete in this cohort Female Estrogen Receptor (+) Breast Cancer Patients Seviteronel Female ER(+) BC Patients - Enrollment is complete in this cohort
- Primary Outcome Measures
Name Time Method Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC. Duration of Study Estimate efficacy of seviteronel as measured by clinical benefit rate at 24 weeks (CBR24) for female subjects with ER+ BC. Duration of Study Estimate efficacy of seviteronel as measured by CBR16 for all male BC subjects. Duration of Study
- Secondary Outcome Measures
Name Time Method Describe the pharmacokinetics of seviteronel At least monthly over the first eight 28-day cycles Area under the curve concentration verses time curve and Peak Plasma Concentration
Estimate efficacy of seviteronel as measured by the overall response rate (ORR) based on RECIST 1.1 At least monthly over the first eight 28-day cycles Estimate efficacy of seviteronel as measured by progression-free survival (PFS) At least monthly over the first eight 28-day cycles Describe the safety profile of seviteronel Duration of the study Compare the safety profile of seviteronel with or without concurrent glucocorticoid administration Duration of the study Compare the CBR16 with or without concurrent glucocorticoid administration for female subjects with TNBC Duration of the study
Trial Locations
- Locations (36)
Mary Crowley Cancer Research Centers
🇺🇸Dallas, Texas, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Oncology Hematology Care, Inc
🇺🇸Cincinnati, Ohio, United States
Florida Cancer Specialists- North
🇺🇸Saint Petersburg, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
SCRI - HCA Midwest Division
🇺🇸Kansas City, Kansas, United States
North Shore Hematology Oncology Associates
🇺🇸East Setauket, New York, United States
Novant Health Presbyterian Medical Center - Oncology Research
🇺🇸Charlotte, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Wallace Tumor Institute- University of Alabama
🇺🇸Birmingham, Alabama, United States
Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States
SCRI Tenessee Oncology Nashville
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Memorial Sloan Kettering
🇺🇸New York, New York, United States
Rocky Mountain Cancer Centers
🇺🇸Lakewood, Colorado, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Maryland Oncology Hematology
🇺🇸Silver Spring, Maryland, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
University of Louisville Hospital / James Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Charleston Hematology and Oncology Associates
🇺🇸Charleston, South Carolina, United States
The Center for Cancer and Blood Disorders (Fort Worth)
🇺🇸Fort Worth, Texas, United States
US Oncology
🇺🇸Fort Worth, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Precision Cancer Research/Brig Center for Cancer Care and Survivorship, LLC
🇺🇸Knoxville, Tennessee, United States
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Cancer Network/Oncology Associates PC
🇺🇸Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Duke University
🇺🇸Durham, North Carolina, United States