Clinical trial NCT02130700: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: mCRPC
metastatic
castration-resistant prostate cancer
Lead sponsor: Innocrin Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-05
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The change in PSA from baseline using waterfall plots in response to 12-weeks of treatment with VT-464
timeFrame: 12 weeks
measure: Progression-free survival using Kaplan-Meier curves
timeFrame: 8 months
measure: 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
timeFrame: 16 weeks
measure: 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
timeFrame: 24 weeks
Secondary outcomes:
measure: Overall survival using Kaplan-Meier curves
timeFrame: 32 months
measure: The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
timeFrame: 8 months
measure: Maximum PSA response compared to baseline
timeFrame: 8 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health, National Cancer Institute
state: Maryland
Study officials:
References: