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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Innocrin Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Innocrin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02012920
First received: December 6, 2013
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity 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 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:
  • The pharmacokinetics of VT-464 using measures that include Cmax, Tmax and AUC [ Time Frame: The first 28-day continuous dosing cycle at target dose. ]

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 ]

Estimated Enrollment: 141
Study Start Date: December 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment-Naive Patients
VT-464: given orally once daily in 28 day cycles
Drug: VT-464: given orally once daily in 28 day cycles
Experimental: Previous abiraterone AND enzalutamide
VT-464: given orally once daily in 28 day cycles
Drug: VT-464: given orally once daily in 28 day cycles

Detailed Description:
This is a Phase 1/2 study of VT-464 in treatment-naïve patients CRPC and CRPC patients who have failed prior therapy with abiraterone, enzalutamide, and/or chemotherapy. The study consists of 2 phases: a dose-escalation phase (Phase 1) and a cohort-expansion phase (Phase 2). Phase 1 will be an open-label, multicenter, sequential-dose cohort design in treatment-naive patients and Phase 2 will be an open-label, multicenter, parallel-group design and treatment-naive and treatment-failure patients.
  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 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 abiraterone (Zytiga®), TAK-700 (Orteronel®), TOK-001 (Galeterone®), or MDV3100, or any other investigational product directed towards the androgen receptor or androgen biosynthesis. Previous abiraterone and enzalutamide are allowed in certain treatment-failure cohorts
  • 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: NCT02012920

Contacts
Contact: Lisa Franklin 919-695-9493 lfranklin@innocrinpharma.com
Contact: Tess Ferrer, BSN 919-695-9614 tferrer@innocrinpharma.com

Locations
United States, Alabama
Urology Centers of Alabama Recruiting
Homewood, Alabama, United States, 35209
Contact: Tosha Pringle    205-414-4423    tpringle@urologyal.com   
Principal Investigator: Mark DeGuenther, MD         
United States, Florida
H. Lee Moffitt Cancer and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Inez Sims, RN    813-745-3892    Inez.Sims@moffitt.org   
Principal Investigator: Shilpa Gupta, MD         
United States, Nebraska
Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
Contact: Sarah Meier, RN, BSN, OCN    402-991-8468    smeier@gucancer.com   
Principal Investigator: Luke Nordquist, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 86169
Contact: Debbie Dios, RN    702-952-3400    Debbie.Dios@usoncology.com   
Principal Investigator: Nicholas J Vogelzang, MD         
Sub-Investigator: Oscar Goodman, MD         
United States, New York
North Shore Hematology Oncology Associates Recruiting
East Setauket, New York, United States, 11733
Contact: Don Marx    631-675-5143    dmarx@NSHOA.com   
Principal Investigator: Jeffrey Vacirca, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Julia Rasmussen, RN    919-681-9822    julia.rasmussen@duke.edu   
Principal Investigator: Daniel George, MD         
Sub-Investigator: William Berry, MD         
Sub-Investigator: Andrew Armstrong, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith    330-492-3345    csmith@grabrailcancercenter.com   
Principal Investigator: Nashat Gabrail, MD         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Griffith    843-449-1010 ext 316    jgriffith@atlanticurologyclinics.com   
Principal Investigator: Neal Shore, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Terminated
Houston, Texas, United States, 77030
United States, Virginia
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Stephanie Griffith, RN    757-213-5637    Stephanie.Griffith@usoncology.com   
Principal Investigator: Mark Fleming, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kelly Simmons, B.A.    608-263-7107    kssimmons@medicine.wisc.edu   
Principal Investigator: Glenn Liu, M.D.         
Greece
Alexandria Hospital, Department of Oncology Recruiting
Athens, Greece, 11528
Contact: Revekka Gyftaki    +30 6937064958    rgyftaki@gmail.com   
Principal Investigator: Eleni Efstathiou, MD, PhD         
Switzerland
Kantonsspital St Gallen, Onkologie/ Hamatologie Recruiting
St Gallen, Switzerland, CH-9007
Contact: Brian Meehan, RN       Brian.Meehan@kssg.ch   
Principal Investigator: Silke Gillessen, MD         
Sub-Investigator: Aurelius Omlin, MD         
United Kingdom
The Royal Marsden Hospital - Institute of Cancer Research Recruiting
Sutton, Surrey, United Kingdom
Contact: Alan Smith, MD       alan.smith@icr.ac.uk   
Principal Investigator: Johann De Bono, MD         
Sub-Investigator: Alan Smith, MD         
Sponsors and Collaborators
Innocrin Pharmaceutical
  More Information

Responsible Party: Innocrin Pharmaceutical
ClinicalTrials.gov Identifier: NCT02012920     History of Changes
Other Study ID Numbers: INO-VT-464-CL-001
VMT-VT-464-CL-001 ( Other Identifier: Innocrin )
Study First Received: December 6, 2013
Last Updated: April 25, 2017

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

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