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Prostate CancerPhase 2NCT02445976

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

A Phase 2 study testing Seviteronel: given orally once daily in 28-day cycles in people with Prostate Cancer, run by Innocrin Pharmaceutical at 21 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 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Seviteronel: given orally once daily in 28-day cycles
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
21 sitesUnited States
Study dates
May 2015to Jan 2019
Phase
Phase 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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be ≥18 years of age.
  • Subjects or their legal representatives must be able to provide written informed consent.
  • Subjects must have documented histological or cytological evidence of adenocarcinoma of the prostate.
  • Subjects must have an ECOG Performance Score of 0-1.
  • 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.
  • 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:
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  • 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
  • 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.
  • 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
  • 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
  • Subjects must have adequate renal function as evidenced by a serum creatinine of <2.0 mg/dl.
  • Subjects must have potassium (K+) >3.5 mEq/l.
  • 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:
  • 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. 13. Subjects able to swallow study medication 14. Subjects able to comply with study requirements

Who cannot join

  • Subjects who have completed sipuleucel-T (Provenge ®) treatment within 28 days of study drug initiation.
  • Subjects on 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of study drug initiation.
  • Subjects who received any investigational agent ≤28 days of study drug initiation.
  • Subjects who received palliative radiotherapy ≤2 weeks of study drug initiation.
  • Subjects with symptomatic CNS metastases.
  • Subjects with a history of another invasive malignancy ≤3 years of study drug initiation.
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  • 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.
  • 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)
  • 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).
  • 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.
  • 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.
  • Subject with a history of loss of consciousness or transient ischemic attack ≤ 12 months of study drug initiation.
  • Subject with known active HIV, Hepatitis B, or Hepatitis C infections.
  • Subject with known or suspected hypersensitivity to seviteronel, or any components of the formulation
  • Subject with any other condition which in the opinion of the investigator would preclude participation in the study.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106

  • University of Alabama

    Birmingham, Alabama, 35249

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • University of California at Los Angeles

    Los Angeles, California, 90095

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53715

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Yale University

    New Haven, Connecticut, 06519

  • Tulane University

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • GU Research Network

    Omaha, Nebraska, 68130

  • Mayo Clinic

    Scottsdale, Arizona, 85054

  • University of Washington

    Seattle, Washington, 98109

  • Washington University

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Seviteronel: given orally once daily in 28-day cycles
Keywords
mCRPC, metastatic, castration-resistant prostate cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Seviteronel: given orally once daily in 28-day cyclesDrug

    Also called Seviteronel

    Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose

Study groups in NCT02445976
Study groupRoleWhat they receive
Prior Abiraterone or EnzalutamideExperimentalSeviteronel: given orally once daily in 28-day cycles
Receives: Drug: Seviteronel: given orally once daily in 28-day cycles
Prior Abiraterone and EnzalutamideExperimentalSeviteronel: given orally once daily in 28-day cycles
Receives: Drug: Seviteronel: given orally once daily in 28-day cycles

What is being measured

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

  1. Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel

    PSA response at any time whilst on study from the start of treatment within seviteronel defined by a ≥ 50% decrease in serum PSA.

    Measured: 6 months

  2. The time to radiographic disease progression by RECIST 1.1 or PCWG3

    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)

    Measured: 10 months

Timeline

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

  1. First posted15 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2018
  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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
197 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02445976
Sponsor's protocol ID
INO-VT-464-CL-003
Other IDs
VMT-VT-464-CL-003
Status last verified
Jan 2019
First submitted
13 May 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 2 study testing Seviteronel: given orally once daily in 28-day cycles in people with Prostate Cancer, run by Innocrin Pharmaceutical at 21 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 26 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 21 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 phase mean?

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?

Proportion of patients who have a PSA response by while on study from starting treatment with seviteronel (time frame: 6 months). The study lists 2 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 NCT02445976.

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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