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Castration-resistant Prostate CancerPhase 2NCT02012920

A Study to Evaluate Oral VT-464 in Patients With Castration-Resistant Prostate Cancer

A Phase 2 study testing Seviteronel: given orally once daily in 28 day cycles in people with Castration-resistant Prostate Cancer and CRPC, run by Innocrin Pharmaceutical at 23 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of Seviteronel, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-resistant Prostate Cancer, CRPC
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
200 participants
Where
23 sitesin 4 countries
Study dates
Dec 2011to 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

  • 1.18 years of age or older 2. Able to provide written informed consent or have their legal representatives provide written informed consent 3. Documented histological or cytological evidence of adenocarcinoma of the prostate. Subjects whose pathology reports are no longer available may be enrolled if, in the opinion of the investigator, the subject has a clinical course consistent with prostatic adenocarcinoma 4. ECOG Performance Status of 0 or 1 5. Undergone orchiectomy, or have ongoing LHRH analogue therapy prior to C1D1. Subjects on LHRH analogues should remain on these agents for the duration of the study 6. Castrate levels of testosterone less than or equal to 50 ng/dl (or 1.7 nmol/L) and have progressive disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values greater than or equal to 1 week between each assessment. The PSA value at the Screening visit must be greater than or equal 2ng/mL with or without: Soft tissue disease progression defined by RECIST 1.1 at Screening or less than or equal to 28 days of C1D1. Measurable disease is not required for entry.
  • Lymph nodes greater than or equal to 1.5cm (short axis) are considered measurable disease bone disease progression defined by greater than or equal 2 new lesions on bone scan at Screening, or less than or equal 28 days of C1D1 7. Have received abiraterone and/or enzalutamide. Subject must have received either abiraterone or enzalutamide for greater than or equal to 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. Adequate hematopoietic function as evidenced by:
  • WBC greater than or equal to 3,000/μl
  • ANC greater than or equal to 1,500/μl
  • Platelet count greater than or equal to 100,000/μl
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  • HGB greater than or equal to 10 g/dl and not transfusion dependent 9. Adequate liver function, including all the following:
  • Total serum bilirubin less than or equal to 2.0 x ULN unless the subject has documented Gilbert syndrome;
  • Aspartate and alanine aminotransferase (AST \& ALT) less than or equal to 3.0 x ULN or less than or equal to 5.0 x ULN if subject has liver metastasis;
  • Alkaline phosphatase less than or equal to 3.0 x ULN or less than or equal to 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 less than or equal to 2.0 mg/dl 11. Potassium (K+) greater than or equal to 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 at Screening and continuing throughout the study period and for 3 months after final study drug administration.
  • Two acceptable forms of birth control include:
  • Condom (barrier method of contraception), and
  • 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 greater than or equal to 6 months prior to Screening.
  • 13. Able to swallow study medication 14. Able to comply with study requirements

Who cannot join

  • Each subject eligible to participate in this study must not have any of the following:
  • Received sipuleucel-T (Provenge ®) treatment within 28 days of C1D1
  • Received 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of C1D1
  • Received any investigational agent less than or equal to 28 days of C1D1
  • Received palliative radiotherapy less than or equal to 2 weeks of C1D1
  • Symptomatic CNS metastases
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  • History of another invasive malignancy less than or equal to 3 years of C1D1
  • A QTcF interval of greater than 470 msec; if the Screening ECG QTcF interval is greater than 470 msec, it may be repeated, and if repeat less than or equal to 470 msec, the subject may be enrolled
  • 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)
  • Started a bone modifying agent (e.g. bisphosphonates, denosumab) less than or equal to 28 days of C1D1 (note: ongoing bone modifying agents administered less than 28 days are allowed)
  • Any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results
  • 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
  • A history of loss of consciousness or transient ischemic attack less than or equal to 12 months of 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

23 sites in 4 countries.

23 sites in 4 countries

United States19 sites

  • Urologic Consultants of Southeastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Duke Cancer Institute at Cary: Medical Oncology

    Cary, North Carolina, 27518

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 86169

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Urology Cancer Center

    Omaha, Nebraska, 68130

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

  • H. Lee Moffitt Cancer and Research Institute

    Tampa, Florida, 33612

  • NY Cancer and Blood Specialists

    The Bronx, New York, 10469

  • Wichita Urology

    Wichita, Kansas, 67226

Other trials in United States

United Kingdom2 sites

  • Guys and St. Thomas' NHS Foundation Trust

    London

  • The Royal Marsden Hospital - Institute of Cancer Research

    Sutton, Surrey

Other trials in United Kingdom

Greece1 site

  • Alexandria Hospital, Department of Oncology

    Athens, 11528

Other trials in Greece

Switzerland1 site

  • Kantonsspital St Gallen, Onkologie/ Hamatologie

    Sankt Gallen, Canton of St. Gallen, CH-9007

Other trials in Switzerland

About this study

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

The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of Seviteronel, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).

Read the detailed description

This is a Phase 1/2 study of seviteronel in subjects with castration-resistant prostate cancer (CRPC). Phase 1 was a dose-escalation study enrolling subjects with CRPC that were either "treatment naïve" (not treated with previous abiraterone or enzalutamide), or treated with one or more of the following: abiraterone, enzalutamide, or chemotherapy.

Phase 2 is an open-label, multi-center cohort-expansion study to further determine the efficacy and safety of seviteronel in two CRPC populations with documented rising PSA with or without bone or soft tissue disease progression during treatment with: abiraterone or enzalutamide for ≥ 12 weeks (Group 1) abiraterone and enzalutamide; treatment should be ≥ 12 weeks for at least one agent (Group 2)

Being tested
Seviteronel: given orally once daily in 28 day cycles
Keywords
castration-resistant prostate cancer, CYP17, P450c17a, lyase, Prostate Cancer
Medical subject headings
Prostatic Neoplasms

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

Study groups in NCT02012920
Study groupRoleWhat they receive
Single Failure of Abiraterone or EnzalutamideExperimentalSeviteronel: given orally once daily in 28 day cycles
Receives: Drug: Seviteronel: given orally once daily in 28 day cycles
Double Failure of Abiraterone and EnzalutimideExperimentalSeviteronel: 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 subjects who have ≥50% PSA decline at any time on study from the start of treatment with seviteronel.

    Review of subjects with defined PSA value decline of greater than or equal to 50% from study start.

    Measured: 6 months

  2. 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

    Review of subject disease progression status via CT and measure of median time to progression if progression occurs.

    Measured: 10 months

Secondary outcomes (1)

  1. Radiographic response rate by RECIST 1.1 & PCWG3. Safety of seviteronel with or without concurrent glucocorticoid administration

    Evaluate RECIST 1.1 response and PCWG3 guidelines for responses.

    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 posted17 Dec 2013 (estimated)
  2. Study startDec 2011
  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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02012920
Sponsor's protocol ID
INO-VT-464-CL-001
Other IDs
VMT-VT-464-CL-001
Status last verified
Jan 2019
First submitted
6 Dec 2013
Last updated
1 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
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 Castration-resistant Prostate Cancer and CRPC, run by Innocrin Pharmaceutical at 23 sites in 4 countries.

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 18 inclusion and 16 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 23 sites in United States, United Kingdom, Greece, Switzerland. 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 subjects who have ≥50% PSA decline at any time on study from the start of 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 NCT02012920.

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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