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Cancer of the BreastPhase 1/2CLARITY-01NCT02580448

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

A Phase 1/2 study testing Seviteronel in people with Cancer of the Breast and Breast Cancer, run by Innocrin Pharmaceutical at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Seviteronel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
36 sitesUnited States
Study dates
Aug 2015to Jan 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • 1. Condom (barrier method of contraception), and 2. One of the following:
  • Oral, injected or implanted hormonal contraception
  • Placement of an intrauterine device (IUD) or intrauterine system (ISU)
  • Additional barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Vasectomy or surgical castration ≥ 6 months prior to Screening. 12. Able to swallow study medication 13. Able to comply with study requirements

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • University of Colorado

    Aurora, Colorado, 80045

  • Wallace Tumor Institute- University of Alabama

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Charleston Hematology and Oncology Associates

    Charleston, South Carolina, 29414

  • Novant Health Presbyterian Medical Center - Oncology Research

    Charlotte, North Carolina, 28204

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45242

  • The Ohio State University

    Columbus, Ohio, 43202

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75230

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • The Center for Cancer and Blood Disorders (Fort Worth)

    Fort Worth, Texas, 76104

  • US Oncology

    Fort Worth, Texas, 76177

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • SCRI - HCA Midwest Division

    Kansas City, Kansas, 61432

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

    Knoxville, Tennessee, 37909

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • University of Louisville Hospital / James Brown Cancer Center

    Louisville, Kentucky, 40202

  • Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • SCRI Tenessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Cancer Network/Oncology Associates PC

    Omaha, Nebraska, 68118

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20902

  • Florida Cancer Specialists- North

    St. Petersburg, Florida, 33705

Other trials in United States

About this study

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

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.

Read the 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

Being tested
Seviteronel
Keywords
Breast Cancer, Breast, Advanced Breast Cancer, Metastatic Breast Cancer, CYP17, Male Breast Cancer, Triple Negative Cancer, ER+ Breast Cancer
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SeviteronelDrug

    Seviteronel given daily with evening meal in 28 day cycles

Study groups in NCT02580448
Study groupRoleWhat they receive
Female Triple Negative Breast Cancer PatientsExperimentalTNBC Patients - Enrollment is complete in this cohort
Receives: Drug: Seviteronel
Female Estrogen Receptor (+) Breast Cancer PatientsExperimentalFemale ER(+) BC Patients - Enrollment is complete in this cohort
Receives: Drug: Seviteronel
Male Breast Cancer PatientsExperimentalLocally advanced or metastatic males with BC
Receives: Drug: Seviteronel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC.

    Measured: Duration of Study

  2. Estimate efficacy of seviteronel as measured by clinical benefit rate at 24 weeks (CBR24) for female subjects with ER+ BC.

    Measured: Duration of Study

  3. Estimate efficacy of seviteronel as measured by CBR16 for all male BC subjects.

    Measured: Duration of Study

Secondary outcomes (6)

  1. Describe the pharmacokinetics of seviteronel

    Area under the curve concentration verses time curve and Peak Plasma Concentration

    Measured: At least monthly over the first eight 28-day cycles

  2. Estimate efficacy of seviteronel as measured by the overall response rate (ORR) based on RECIST 1.1

    Measured: At least monthly over the first eight 28-day cycles

  3. Estimate efficacy of seviteronel as measured by progression-free survival (PFS)

    Measured: At least monthly over the first eight 28-day cycles

  4. Describe the safety profile of seviteronel

    Measured: Duration of the study

  5. Compare the safety profile of seviteronel with or without concurrent glucocorticoid administration

    Measured: Duration of the study

  6. Compare the CBR16 with or without concurrent glucocorticoid administration for female subjects with TNBC

    Measured: Duration of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02580448
Sponsor's protocol ID
INO-VT-464-CL-006
Acronym
CLARITY-01
Status last verified
Jan 2019
First submitted
7 Oct 2015
Last updated
1 Feb 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Seviteronel in people with Cancer of the Breast and Breast Cancer, run by Innocrin Pharmaceutical at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate efficacy of seviteronel as measured by clinical benefit rate at 16 weeks (CBR16) for female subjects with TNBC. (time frame: Duration of Study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02580448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.

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