A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel in Subjects With Advanced Breast Cancer
Overview
- Phase
- Phase 1
- Intervention
- Seviteronel
- Conditions
- Cancer of the Breast
- Sponsor
- Innocrin Pharmaceutical
- Enrollment
- 175
- Locations
- 36
- Primary Endpoint
- Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Female Triple Negative Breast Cancer Patients
TNBC Patients - Enrollment is complete in this cohort
Intervention: Seviteronel
Female Estrogen Receptor (+) Breast Cancer Patients
Female ER(+) BC Patients - Enrollment is complete in this cohort
Intervention: Seviteronel
Male Breast Cancer Patients
Locally advanced or metastatic males with BC
Intervention: Seviteronel
Outcomes
Primary Outcomes
Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC.
Time Frame: Duration of Study
Estimate efficacy of seviteronel as measured by clinical benefit rate at 24 weeks (CBR24) for female subjects with ER+ BC.
Time Frame: Duration of Study
Estimate efficacy of seviteronel as measured by CBR16 for all male BC subjects.
Time Frame: Duration of Study
Secondary Outcomes
- Describe the pharmacokinetics of seviteronel(At least monthly over the first eight 28-day cycles)
- 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)