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

NCT02130700 | Completed Phase 2

• 2 other identifiers: INO-VT-464-CL-002VMT-VT-464-CL-002
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

mCRPC; metastatic; castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (4)

• The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464

  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.

  12 weeks

• Progression-free survival using Kaplan-Meier curves

  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.

  8 months

• 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

  Clinical benefit rate will be measured at designated timepoints as listed per protocol

  16 weeks

• 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

  Clinical benefit rate will be measured at designated timepoints as listed per protocol

  24 weeks

Secondary Outcomes (3)

• Overall survival using Kaplan-Meier curves

  32 months

• The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.

  8 months

• Maximum PSA response compared to baseline

  8 months

Study Arms (5)

Chemotherapy-Naive Patients

EXPERIMENTAL

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

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

Previous Chemotherapy Patients

EXPERIMENTAL

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

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

AR Positive 1 - 9% TNBC

EXPERIMENTAL

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

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

Male ER Positive

EXPERIMENTAL

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

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

AR Positive >10% TNBC

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: VT-464

Chemotherapy-Naive Patients; Previous Chemotherapy Patients

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

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

Also known as: seviteronel

AR Positive 1 - 9% TNBC; AR Positive >10% TNBC; Male ER Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Innocrin Pharmaceutical: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Institutes of Health, National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

VT-464; seviteronel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: May 5, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)