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

NCT ID: NCT02130700

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-11-30

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy-Naive Patients

VT-464: given orally twice daily in 28-day cycles

Group Type: EXPERIMENTAL

VT-464: given orally twice daily in 28-day cycles

Intervention Type: DRUG

Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose

Previous Chemotherapy Patients

VT-464: given orally twice daily in 28-day cycles

Group Type: EXPERIMENTAL

VT-464: given orally twice daily in 28-day cycles

Intervention Type: DRUG

Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose

AR Positive 1 - 9% TNBC

VT-464: given orally once daily in 28-day cycles

Group Type: EXPERIMENTAL

VT-464: given orally once daily in 28-day cycles

Intervention Type: DRUG

Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose

Male ER Positive

VT-464: given orally once daily in 28-day cycles

Group Type: EXPERIMENTAL

VT-464: given orally once daily in 28-day cycles

Intervention Type: DRUG

Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose

AR Positive >10% TNBC

VT-464: given orally once daily in 28-day cycles

Group Type: EXPERIMENTAL

VT-464: given orally once daily in 28-day cycles

Intervention Type: DRUG

Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

VT-464; seviteronel

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Innocrin Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Institutes of Health, National Cancer Institute

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

VMT-VT-464-CL-002

Identifier Type: OTHER

Identifier Source: secondary_id

INO-VT-464-CL-002

Identifier Type: -

Identifier Source: org_study_id

NCT02117531

Identifier Type: -

Identifier Source: nct_alias