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CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel in Subjects With Advanced Breast Cancer

NCT02580448•Innocrin Pharmaceutical

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Each subject eligible to participate in this study must meet or have all the following criteria:
•1. Is 18 years of age or older.
•2. Can provide written informed consent or have their legal representatives provide written informed consent
•3. Have documented histological or cytological evidence of invasive cancer of the breast, defined by one of the following:
•* ER+ breast cancer, defined as positive if ≥ 1% by IHC and HER2 normal, defined as IHC 0-1+ or IHC 2+(and FISH\<2), or FISH \< 2.0
•* TNBC, defined as ER-/PgR- if 0 % by IHC and HER2 normal, defined as IHC 0-1+ or IHC 2+(and FISH\<2), or FISH \< 2.0
•4. ECOG PS of 0 or 1 for Females, 0, 1, or 2 for Males.
•5. Undergoing or willing to undergo gonadal suppression:
•* Female subjects with ER+/HER2 normal tumors must be post-menopausal defined by local practice. Ovarian suppression with a LHRH analogue to achieve cessation of regular menses is allowed on study
•* Male subjects must be undergoing or willing to undergo gonadal suppression whilst on study drug and continue with the LHRH analogue for the duration of the study
+18 more criteria

Exclusion Criteria

•1. Received any investigational agent within 5 half-lives of the agent in question; if the half-life is not known, ≤ 28 days of C1D1.
•2. Received palliative radiotherapy ≤ 2 weeks of C1D1
•3. Received any other therapeutic treatment for breast cancer ≤ 2 weeks of C1D1, except for hormonal therapies.
•4. Symptomatic CNS metastases.
•5. History of another invasive malignancy ≤ 3 years of C1D1.
•6. A QTcF interval \>470 msec on the Screening ECG. If the ECG QTcF interval is \>470 msec, then the mean QTcF of a triplicate ECGs can be used and if the mean is \<470 msec, the subject may be enrolled.
•7. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, atrial fibrillation with rapid ventricular response, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place).
•8. Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months
•9. Initiated a bone modifying agent (e.g. denosumab) ≤ 28 days of C1D1.
•10. Any medical condition that could preclude their participation in the study, pose an undue medical hazard, or which could interfere with the interpretation of the study results.
+5 more criteria

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

St. 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

Key Dates

Start Date

August 1, 2015

Primary Completion Date

January 1, 2019

Completion Date

January 1, 2019

Last Updated

February 1, 2019

Enrollment

175

ESTIMATED participants

Conditions

Cancer of the BreastBreast CancerAdvanced Breast CancerMetastatic Breast CancerMale Breast CancerTriple Negative Breast CancerER+ Breast Cancer

Interventions

Seviteronel

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer