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

Completed · Phase 1/Phase 2

Conditions studied: Cancer of the Breast, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Male Breast Cancer, Triple Negative Breast Cancer, ER+ Breast Cancer

In brief

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.

Key facts

Study ID

NCT02580448

Run by

Innocrin Pharmaceutical

People needed

175

Starts

2015-08-01

Expected to finish

2019-01-01

Last updated by the study team

2019-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Adequate liver function, including all the following:
• Total serum bilirubin ≤2.0 x ULN unless the subject has documented Gilbert syndrome;
• Aspartate and alanine aminotransferase (AST \& ALT) ≤3.0 x ULN or ≤5.0 x ULN if subject has liver metastasis;
• Alkaline phosphatase ≤3.0 x ULN or ≤5 x ULN in case of bone metastasis and/or hepatic metastasis
• Subjects must have adequate renal function as evidenced by a serum creatinine of ≤ 2.0 mg/dl.
• Potassium (K+) ≥3.5 mEq/L
• Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours of C1D1.
• Women of child-bearing potential and male subjects with a female partner of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period and for 3 months after final study drug administration i. Two acceptable forms of birth control include:
• Condom (barrier method of contraception), and 2. One of the following:
• Oral, injected or implanted hormonal contraception

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.

Where it is running

• 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
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Masonic Cancer Center — Minneapolis, Minnesota, United States
• Cancer Network/Oncology Associates PC — Omaha, Nebraska, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• North Shore Hematology Oncology Associates — East Setauket, New York, United States
• Memorial Sloan Kettering — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Novant Health Presbyterian Medical Center - Oncology Research — Charlotte, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Oncology Hematology Care, Inc — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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