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Castration-resistant Prostate CancerPhase 1/2NCT02361086

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

A Phase 1/2 study testing VT-464: given orally once daily in 28 day cycles in people with Castration-resistant Prostate Cancer and CRPC, run by Innocrin Pharmaceutical at 5 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, tolerability, pharmacokinetics and activity of once-daily (QD) oral dosing of VT-464, 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?
VT-464: 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
21 participants
Where
5 sitesUnited States
Study dates
Jun 2014to Jun 2018
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
  • Patients must have a minimum serum PSA level of >2 ng/ml that is rising based on the Prostate Cancer Working Group 2 criteria.
  • Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]).
  • Patients must have undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study entry. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
  • Patients must have an ECOG Performance Score of 0 or 1.

Who cannot join

  • Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
  • Patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
  • Patients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.
  • Patients who have received TOK-001 (Galeterone®) or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
  • Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for > 3 months must be off treatment for 6 weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for < 3 months must be off medication for 2 weeks. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) must stop medication at least 3 months from study entry.
  • Patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
  • Patients who have received palliative radiotherapy within 4 weeks of study entry.
  • Patients with a history within the last 3 years of another invasive malignancy.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Urology Cancer Center

    Omaha, Nebraska, 68130

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Once-Daily VT-464 in Patients With Castration-Resistant Prostate Cancer

The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of once-daily (QD) oral dosing of VT-464, 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 VT-464 in chemotherapy-naïve CRPC patients who are treatment-naive or who have failed prior therapy with abiraterone and/or enzalutamide. The study will examine several parallel QD dosing regimens of VT-464 using a traditional modified "3+3" Fibonacci study design. Approximately 3 dose-levels of VT-464 will be examined in each dosing regimen that is fully enrolled.

Being tested
VT-464: given orally once daily in 28 day cycles
Keywords
castration-resistant prostate cancer, CYP17, P450c17a, lyase

What participants receive

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

  • VT-464: given orally once daily in 28 day cyclesDrug

    Also called VT-464

    VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.

Study groups in NCT02361086
Study groupRoleWhat they receive
Regimen 1: 7dayPM+DTExperimentalVT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week with a 2-week dose titration.
Receives: Drug: VT-464: given orally once daily in 28 day cycles
Regimen 2: 7dayPM-DTExperimentalVT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.
Receives: Drug: VT-464: given orally once daily in 28 day cycles
Regimen 3: 7dayAM+DTExperimentalVT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.
Receives: Drug: VT-464: given orally once daily in 28 day cycles
Regimen 4: 7dayAM-DTExperimentalVT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.
Receives: Drug: VT-464: given orally once daily in 28 day cycles
Regimen 5: 5dayPM-DTExperimentalVT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.
Receives: Drug: VT-464: given orally once daily in 28 day cycles
Regimen 6: 5dayAM-DTExperimentalVT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.
Receives: Drug: VT-464: 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. The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.

    Measured: The first 28-day continuous dosing cycle at target dose.

Secondary outcomes (3)

  1. Peak Plasma Concentration (Cmax) of VT-464

    Measured: After the first dose of VT-464

  2. Area under the plasma concentration versus time curve (AUC) of VT-464

    Measured: After the first dose of VT-464

  3. Time to maximum plasma concentration (Tmax) of VT-464

    Measured: After the first dose of VT-464

Timeline

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

  1. First posted11 Feb 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2017
  4. Study completionJun 2018

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02361086
Sponsor's protocol ID
INO-VT-464-CL-004
Status last verified
Jan 2019
First submitted
29 Jan 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 VT-464: given orally once daily in 28 day cycles in people with Castration-resistant Prostate Cancer and CRPC, run by Innocrin Pharmaceutical at 5 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 5 inclusion and 8 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 5 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?

The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests. (time frame: The first 28-day continuous dosing cycle at target dose.). 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 NCT02361086.

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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