CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)

Phase 1

Completed

• Conditions: Cancer of the Breast; Breast Cancer; Male Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; Triple Negative Breast Cancer; ER+ Breast Cancer
• Interventions: Drug: Seviteronel

• 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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-20
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

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)

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

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