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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Innocrin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02361086
First received: January 29, 2015
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Castration-resistant Prostate Cancer CRPC Drug: VT-464: given orally once daily in 28 day cycles Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Innocrin Pharmaceutical:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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 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.
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 4: 7dayAM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.
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 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.
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 6: 5dayAM-DT
VT-464: given orally once daily in 28 day cycles.Dosing in the morning 5-days a week without dose titration.
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

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.
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02361086

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Nebraska
Urology Cancer Center
Omaha, Nebraska, United States, 68130
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Innocrin Pharmaceutical
Investigators
Study Director: Joel Eisner Innocrin Pharmaceutical
  More Information

Responsible Party: Innocrin Pharmaceutical
ClinicalTrials.gov Identifier: NCT02361086     History of Changes
Other Study ID Numbers: INO-VT-464-CL-004
Study First Received: January 29, 2015
Last Updated: February 28, 2017

Keywords provided by Innocrin Pharmaceutical:
castration-resistant prostate cancer
CYP17
P450c17a
lyase

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

ClinicalTrials.gov processed this record on September 21, 2017