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Once-daily Oral Seviteronel in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.

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ClinicalTrials.gov Identifier: NCT02445976
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : November 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this clinical study is to determine the efficacy and safety of Seviteronel, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide and/or abiraterone.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Seviteronel: given orally once daily in 28-day cycles Phase 2

Detailed Description:
This is a phase 2 clinical trial of Seviteronel (an oral, potent and lyase-selective CYP17 inhibitor) in men with castration-resistant prostate cancer (CRPC) progressing on enzalutamide or abiraterone. Approximately 197 subjects will be used to assess treatment efficacy. The study will be conducted in two different clinical cohorts separated by prior exposure to enzalutamide or abiraterone, or prior exposure to enzalutamide and abiraterone.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 197 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study to Evaluate the Efficacy and Safety of Seviteronel in Subjects With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Prior Abiraterone or Enzalutamide
Seviteronel: given orally once daily in 28-day cycles
Drug: Seviteronel: given orally once daily in 28-day cycles
Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Name: Seviteronel
Experimental: Prior Abiraterone and Enzalutamide
Seviteronel: given orally once daily in 28-day cycles
Drug: Seviteronel: given orally once daily in 28-day cycles
Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Name: Seviteronel

Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel [ Time Frame: 6 months ]
    PSA response at any time whilst on study from the start of treatment within seviteronel defined by a ≥ 50% decrease in serum PSA.

  2. The time to radiographic disease progression by RECIST 1.1 or PCWG3 [ Time Frame: 10 months ]
    Median time to radiographic disease progression evaluated by computerized tomography (CT scan) or magnetic resonance imaging (MRI) and radionuclide bone scans by RECIST 1.1 or Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Subjects must be ≥18 years of age.
  2. Subjects or their legal representatives must be able to provide written informed consent.
  3. Subjects must have documented histological or cytological evidence of adenocarcinoma of the prostate.
  4. Subjects must have an ECOG Performance Score of 0-1.
  5. Subjects must have undergone orchiectomy, or have ongoing LHRH analogue therapy prior to drug initiation. Subjects on LHRH analogues must remain on these agents for the duration of the study.
  6. Subjects must have castrate levels of testosterone (≤50 ng/dl [1.7 nmol/L]) and have progressive disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values ≥1 week between each assessment. The PSA value at the Screening visit must be ≥2ng/mL with or without:

    • Soft tissue disease progression defined by RECIST 1.1 at Screening or ≤ 28 days of C1D1. Measurable disease is not required for entry. Lymph nodes ≥ 1.5cm (short axis) are considered measurable disease (PCWG3)
    • Bone disease progression defined by ≥2 new lesions on bone scan at Screening, or ≤28 days of C1D1
  7. Subjects must have received abiraterone and/or enzalutamide. Subject must have received either abiraterone or enzalutamide for ≥12 weeks. Other second generation CYP17 inhibitors/androgen receptor antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place of enzalutamide.
  8. Subjects must have adequate hematopoietic function as evidenced by:

    • WBC ≥3,000/µl
    • ANC ≥1,500/µl
    • Platelet count ≥100,000/µl
    • HGB ≥10 g/dl and not transfusion dependent
  9. Subjects must have adequate liver function, including all of 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 ≤2.0 x ULN or ≤5 x ULN in case of bone metastasis and/or hepatic metastasis
  10. Subjects must have adequate renal function as evidenced by a serum creatinine of <2.0 mg/dl.
  11. Subjects must have potassium (K+) >3.5 mEq/l.
  12. Subject and his female partner who is 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 a Screening and continuing throughout the study period and for 3 months after final study drug administration • Two acceptable forms of birth control include:

1. Condom (barrier method of contraception), and 2. One of the following:

  1. Oral, injected or implanted hormonal contraception
  2. Placement of an intrauterine device (IUD) or intrauterine system (ISU)
  3. Additional barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  4. Vasectomy or surgical castration ≥ 6 months prior to Screening. 13. Subjects able to swallow study medication 14. Subjects able to comply with study requirements

Exclusion Criteria

  1. Subjects who have completed sipuleucel-T (Provenge ®) treatment within 28 days of study drug initiation.
  2. Subjects on 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of study drug initiation.
  3. Subjects who received any investigational agent ≤28 days of study drug initiation.
  4. Subjects who received palliative radiotherapy ≤2 weeks of study drug initiation.
  5. Subjects with symptomatic CNS metastases.
  6. Subjects with a history of another invasive malignancy ≤3 years of study drug initiation.
  7. Subjects with a QTcF interval of >470 msec; if the Screening ECG QTcF interval is >470 msec, it may be repeated, and if repeat <470 msec, the subject may be enrolled.
  8. Subject with clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place)
  9. Subject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ≤ 28 days of study drug initiation (note: ongoing bone modifying agents administered > 28 days are allowed).
  10. Subject with any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results.
  11. Subject with Class III or IV Congestive Heart Failure as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months.
  12. Subject with a history of loss of consciousness or transient ischemic attack ≤ 12 months of study drug initiation.
  13. Subject with known active HIV, Hepatitis B, or Hepatitis C infections.
  14. Subject with known or suspected hypersensitivity to seviteronel, or any components of the formulation
  15. Subject with any other condition which in the opinion of the investigator would preclude participation in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445976

Contact: Saundra Kirven 984-777-5301 skirven@innocrinpharma.com
Contact: Lisa Franklin 919-695-9493 lfranklin@innocrinpharma.com

  Hide Study Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35249
Contact: Anna Messer    205-975-0370    amesser@uab.edu   
Principal Investigator: Guru Sonpavde, MD         
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85054
Contact: Morgan Hope    480-342-6010    hope.morgan@mayo.edu   
Principal Investigator: Alan Bryce, MD         
United States, California
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Colleen Mathis    310-794-2731    cmathis@mednet.ucla.edu   
Principal Investigator: Allan Pantuck, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Matthew Piscatelli    203-785-6821    matthew.piscatelli@yale.edu   
Principal Investigator: Daniel Petrylak, MD         
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kendra Brown    904-953-7755    brown.kendra@mayo.edu   
Principal Investigator: Winston Tan, MD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jesse Mocha    813-745-2629    jesse.mocha@moffitt.org   
Principal Investigator: Jingsong Zhang, MD         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patrick Cotogno    504-988-6542    pcotogno@tulane.edu   
Principal Investigator: Oliver Sartor, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Cesar Vasquez       cvazquez@bidmc.harvard.edu   
Sub-Investigator: Glenn Bubley, MD         
Principal Investigator: Mary-Ellen Taplin, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christopher Anderson    617-632-5505    ChristopherJ_Anderson@dfci.harvard.edu   
Contact: Zachary Melnick       ZacharyJ_Melnick@DFCI.HARVARD.EDU   
Principal Investigator: Mary-Ellen Taplin, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Kim Dobson    313-576-9837    dobsonk@karmanos.org   
Principal Investigator: Ulka Vaishampayan, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Felicia O'Neill    612-626-2569    foneill@umn.edu   
Principal Investigator: Shilpa Gupta, MD         
United States, Missouri
Washington University Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
GU Research Network Recruiting
Omaha, Nebraska, United States, 68130
Contact: Kim Baird    402-991-8468    kbaird@gucancer.com   
Contact: Diane         
Principal Investigator: Luke Nordquist, MD         
United States, New Mexico
New Mexico Cancer Care Alliance Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Kim Steinberg    505-925-0385    sakhand@nmcca.org   
Principal Investigator: Richard Lauer, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Melanie Hullings       hullingm@mskcc.org   
Contact: Stephanie Fox       foxs1@mskcc.org   
Principal Investigator: Howard Scher, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Maxx Perlmutt    919-360-8282    max_perlmutt@med.unc.edu   
Principal Investigator: Young Whang, MD         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Griffith    843-449-1010 ext 316    jgriffith@atlanticurologyclinics.com   
Principal Investigator: Neal Shore, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Julio Torres    434-982-4110    JT4GS@hscmail.mcc.virginia.edu   
Principal Investigator: Robert Dreicer, MD         
Virginia Oncology Associates Recruiting
Hampton, Virginia, United States, 23666
Contact: Jessica Kennedy    757-213-5614    jessica.kennedy@usoncology.com   
Principal Investigator: Mark Fleming, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Kelly Crowder    206-288-7486    kcrowder@seattlecca.org   
Contact: Jessica Maes    206-288-7615    jmaes@seattlecca.org   
Principal Investigator: Bruce Montgomery, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53715
Contact: Jamie Wiepz    608-263-7107    jkwiepz@uwcarbone.wisc.edu   
Principal Investigator: Christos Kyriakopoulos, MD         
Sponsors and Collaborators
Innocrin Pharmaceutical
Prostate Cancer Foundation
Prostate Cancer Clinical Trials Consortium
More Information

Responsible Party: Innocrin Pharmaceutical
ClinicalTrials.gov Identifier: NCT02445976     History of Changes
Other Study ID Numbers: INO-VT-464-CL-003
VMT-VT-464-CL-003 ( Other Identifier: Innocrin )
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Innocrin Pharmaceutical:
castration-resistant prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases