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

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ClinicalTrials.gov Identifier: NCT02361086
Recruitment Status : Active, not recruiting
First Posted : February 11, 2015
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Innocrin Pharmaceutical

January 29, 2015
February 11, 2015
March 1, 2018
June 2014
December 2017   (Final data collection date for 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. ]
Same as current
Complete list of historical versions of study NCT02361086 on ClinicalTrials.gov Archive Site
  • Peak Plasma Concentration (Cmax) of VT-464 [ Time Frame: After the first dose of VT-464 ]
  • Area under the plasma concentration versus time curve (AUC) of VT-464 [ Time Frame: After the first dose of VT-464 ]
  • Time to maximum plasma concentration (Tmax) of VT-464 [ Time Frame: After the first dose of VT-464 ]
Same as current
  • The change in PSA from baseline using waterfall plots in response to VT-464 [ Time Frame: At least monthly over the first 8 28-day dosing cycles ]
  • Objective tumor response to VT-464 at the end of even-numbered cycles using RECIST 1.1 criteria [ Time Frame: At least every other month over the first 8 28-day dosing cycles ]
  • The absolute and percent change from baseline in adrenal, pituitary, and testicular hormone concentrations in response to VT-464 [ Time Frame: At least monthly over the first 8 28-day dosing cycles ]
Same as current
 
A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer
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).
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Castration-resistant Prostate Cancer
  • CRPC
Drug: VT-464: given orally once daily in 28 day cycles
VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
Other Name: VT-464
  • Experimental: Regimen 1: 7dayPM+DT
    VT-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.
    Intervention: Drug: VT-464: given orally once daily in 28 day cycles
  • Experimental: Regimen 2: 7dayPM-DT
    VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.
    Intervention: Drug: VT-464: given orally once daily in 28 day cycles
  • Experimental: Regimen 3: 7dayAM+DT
    VT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.
    Intervention: Drug: VT-464: given orally once daily in 28 day cycles
  • Experimental: Regimen 4: 7dayAM-DT
    VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.
    Intervention: Drug: VT-464: given orally once daily in 28 day cycles
  • Experimental: Regimen 5: 5dayPM-DT
    VT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.
    Intervention: Drug: VT-464: given orally once daily in 28 day cycles
  • Experimental: Regimen 6: 5dayAM-DT
    VT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.
    Intervention: Drug: VT-464: given orally once daily in 28 day cycles
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
54
June 2018
December 2017   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02361086
INO-VT-464-CL-004
No
Not Provided
Not Provided
Innocrin Pharmaceutical
Innocrin Pharmaceutical
Not Provided
Study Director: Joel Eisner Innocrin Pharmaceutical
Innocrin Pharmaceutical
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP