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Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Innocrin Pharmaceutical
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Innocrin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02130700
First received: April 22, 2014
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.

Condition Intervention Phase
Prostate Cancer Drug: VT-464: given orally twice daily in 28-day cycles Drug: VT-464: given orally once daily in 28-day cycles 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 2 Open-Label Study to Evaluate the Efficacy and Safety of VT-464 in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Previously Been Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Innocrin Pharmaceutical:

Primary Outcome Measures:
  • The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464 [ Time Frame: 12 weeks ]
    To determine the PSA response as defined by a ≥ 50% decrease in serum PSA per the Prostate Cancer Clinical Trials Working Group 2 criteria after each cycle and after 12 weeks of dosing with VT-464 compared to PSA level at baseline in patients who have been previously treated with enzalutamide.

  • Progression-free survival using Kaplan-Meier curves [ Time Frame: 8 months ]
    Kaplan-Meier curves of progression-free survival (PFS) will be constructed in each cohort and the median PFS will be determined and informally compared to any available results.

  • Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer [ Time Frame: 16 weeks ]
    Clinical benefit rate will be measured at designated timepoints as listed per protocol

  • Determine clinical benefit rate (CBR) as defined by complete response (CR), partial response (PR) or stable disease (SD) in women with androgen receptor (AR) positive, triple-negative breast cancer [ Time Frame: 24 weeks ]
    Clinical benefit rate will be measured at designated timepoints as listed per protocol


Secondary Outcome Measures:
  • Overall survival using Kaplan-Meier curves [ Time Frame: 32 months ]
    Overall Survival: will be analyzed similarly to PFS, with a separate Kaplan-Meier curve for each arm. A patient for whom there is no death event will be censored; the censored date will be the date of last contact.

  • The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests. [ Time Frame: 8 months ]
    The safety of VT-464 will be evaluated by laboratory evaluation, electrocardiogram, the report of adverse events and concomitant medications at each 28-day cycle of treatment and 4-5 weeks after therapy has been discontinued.

  • Maximum PSA response compared to baseline [ Time Frame: 8 months ]
    Maximum PSA response will be descriptive in nature and presented for each cohort as a percent of patients and as a waterfall plot.


Estimated Enrollment: 48
Study Start Date: April 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy-Naive Patients
VT-464: given orally twice daily in 28-day cycles
Drug: VT-464: given orally twice daily in 28-day cycles
Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Name: VT-464
Experimental: Previous Chemotherapy Patients
VT-464: given orally twice daily in 28-day cycles
Drug: VT-464: given orally twice daily in 28-day cycles
Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Name: VT-464
Experimental: AR Positive 1 - 9% TNBC
VT-464: given orally once daily in 28-day cycles
Drug: VT-464: given orally once daily in 28-day cycles
Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Name: seviteronel
Experimental: Male ER Positive
VT-464: given orally once daily in 28-day cycles
Drug: VT-464: given orally once daily in 28-day cycles
Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Name: seviteronel
Experimental: AR Positive >10% TNBC
VT-464: given orally once daily in 28-day cycles
Drug: VT-464: given orally once daily in 28-day cycles
Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
Other Name: seviteronel

Detailed Description:
This is a Phase 2 open-label study of VT-464 in patients with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with enzalutamide, female patients with triple negative, AR positive breast cancer and men with ER positive breast cancer. The study consists of five cohorts: patients in Cohort 1 must have never received prior chemotherapy. Patients in Cohort 2 must have received at least one (and not more) prior course of chemotherapy for CRPC. Women with TNBC will be stratified into two cohorts AR 1 to 9% (cohort 3) and AR > 10% (cohort 4). Cohort 5 will consist of men who have been diagnosed with ER+ breast cancer and have failed at least one prior endocrine therapy.
  Eligibility

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

Key Eligibility Criteria:

  • Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
  • Must have progressive, metastatic castration-resistant prostate cancer (mCRPC). There must be radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising PSA levels on successive measurements) despite adequate androgen-deprivation therapy, which is defined as having undergone bilateral surgical castration or continued treatment on GnRH agonists or antagonists.
  • All patients in this trial must have been treated with enzalutamide.
  • Patients in Cohort 1 will not be allowed to have received prior chemotherapy; patients in Cohort 2 must have received one (and not more) prior course of chemotherapy for mCRPC.
  • Progression must be evidenced and documented by any of the following parameters:

    • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination
    • Appearance of one or more new lesions on bone scan
    • Progressive measurable disease by RECIST 1.1
  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: NCT02130700

Locations
United States, Maryland
National Institutes of Health, National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact: Helen Owens, RN, BSN    301-435-5612    helen.owens@nih.gov   
Principal Investigator: Ravi Madan, MD         
Sponsors and Collaborators
Innocrin Pharmaceutical
National Cancer Institute (NCI)
  More Information

Responsible Party: Innocrin Pharmaceutical
ClinicalTrials.gov Identifier: NCT02130700     History of Changes
Obsolete Identifiers: NCT02117531
Other Study ID Numbers: INO-VT-464-CL-002
VMT-VT-464-CL-002 ( Other Identifier: Innocrin )
Study First Received: April 22, 2014
Last Updated: February 28, 2017

Keywords provided by Innocrin Pharmaceutical:
mCRPC
metastatic
castration-resistant prostate cancer

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017