CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
NCT02580448 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 175
Last updated 2019-02-01
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.
Conditions
- Cancer of the Breast
- Breast Cancer
- Advanced Breast Cancer
- Metastatic Breast Cancer
- Male Breast Cancer
- Triple Negative Breast Cancer
- ER+ Breast Cancer
Interventions
- DRUG
-
Seviteronel
Seviteronel given daily with evening meal in 28 day cycles
Sponsors & Collaborators
-
Innocrin Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Victoria Brown, BS · Sponsor GmbH
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2019-01-31
- Completion
- 2019-01-31
Countries
- United States
Study Locations
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