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

NCT02580448 | Completed Phase 1

• 1 other identifier: INO-VT-464-CL-006
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 36

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.

Conditions

Cancer of the Breast; Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; Male Breast Cancer; Triple Negative Breast Cancer; ER+ Breast Cancer

Keywords

Breast Cancer; Breast; Advanced Breast Cancer; Metastatic Breast Cancer; CYP17; Male Breast Cancer; Triple Negative Cancer; ER+ Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (3)

Female Triple Negative Breast Cancer Patients

EXPERIMENTAL

TNBC Patients - Enrollment is complete in this cohort

Drug: Seviteronel

Female Estrogen Receptor (+) Breast Cancer Patients

EXPERIMENTAL

Female ER(+) BC Patients - Enrollment is complete in this cohort

Drug: Seviteronel

Male Breast Cancer Patients

EXPERIMENTAL

Locally advanced or metastatic males with BC

Drug: Seviteronel

Interventions

Seviteronel DRUG

Seviteronel given daily with evening meal in 28 day cycles

Female Estrogen Receptor (+) Breast Cancer Patients; Female Triple Negative Breast Cancer Patients; Male Breast Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject eligible to participate in this study must meet or have all the following criteria:
• Is 18 years of age or older.
• Can provide written informed consent or have their legal representatives provide written informed consent
• 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
• ECOG PS of 0 or 1 for Females, 0, 1, or 2 for Males.
• 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
• Subjects must have adequate hematopoietic function as evidenced by:
• WBC ≥ 3,000/μl
• ANC ≥ 1,500/μl
• Platelet count ≥ 100,000/μl
• HGB ≥ 9 g/dl and not transfusion dependent

You may not qualify if:

• Received any investigational agent within 5 half-lives of the agent in question; if the half-life is not known, ≤ 28 days of C1D1.
• Received palliative radiotherapy ≤ 2 weeks of C1D1
• Received any other therapeutic treatment for breast cancer ≤ 2 weeks of C1D1, except for hormonal therapies.
• Symptomatic CNS metastases.
• History of another invasive malignancy ≤ 3 years of C1D1.
• 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.
• 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).
• 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
• Initiated a bone modifying agent (e.g. denosumab) ≤ 28 days of C1D1.
• 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.
• A history of seizure ≤ 2 years of C1D1 or those who require prophylactic anti-seizure medications.
• A history of loss of consciousness or transient ischemic attack ≤ 12 months before C1D1.
• Known active HIV, Hepatitis B, or Hepatitis C infections.
• Known or suspected hypersensitivity to seviteronel, or any components of the formulation.
• Any other condition which in the opinion of the investigator would preclude participation in the study.

Sponsors & Collaborators

• Innocrin Pharmaceutical: lead

Study Sites (36)

Wallace Tumor Institute- University of Alabama

Birmingham, Alabama, 35249, United States

Location

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Cancer Centers

Lakewood, Colorado, 80228, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Florida Cancer Specialists- North

St. Petersburg, Florida, 33705, United States

Location

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

SCRI - HCA Midwest Division

Kansas City, Kansas, 61432, United States

Location

University of Louisville Hospital / James Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Maryland Oncology Hematology

Silver Spring, Maryland, 20902, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Cancer Network/Oncology Associates PC

Omaha, Nebraska, 68118, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

North Shore Hematology Oncology Associates

East Setauket, New York, 11733, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Novant Health Presbyterian Medical Center - Oncology Research

Charlotte, North Carolina, 28204, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States

Location

The Ohio State University

Columbus, Ohio, 43202, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Charleston Hematology and Oncology Associates

Charleston, South Carolina, 29414, United States

Location

Precision Cancer Research/Brig Center for Cancer Care and Survivorship, LLC

Knoxville, Tennessee, 37909, United States

Location

SCRI Tenessee Oncology Nashville

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The Center for Cancer and Blood Disorders (Fort Worth)

Fort Worth, Texas, 76104, United States

Location

US Oncology

Fort Worth, Texas, 76177, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male; Triple Negative Breast Neoplasms

Interventions

seviteronel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Victoria Brown, BS

  Sponsor GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 20, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

US (36)