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
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/9/2018 |
| Start Date: | April 2014 |
| End Date: | November 2017 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
Bethesda, Maryland 20892
Principal Investigator: Ravi Madan, MD
Phone: 301-435-5612
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