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

Innocrin Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02130700

VMT-VT-464-CL-002 (Other Identifier)

INO-VT-464-CL-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 5 patient groups

Chemotherapy-Naive Patients

Experimental group

Description:

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

Treatment:

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

Previous Chemotherapy Patients

Experimental group

Description:

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

Treatment:

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

AR Positive 1 - 9% TNBC

Experimental group

Description:

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

Treatment:

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

Male ER Positive

Experimental group

Description:

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

Treatment:

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

AR Positive >10% TNBC

Experimental group

Description:

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

Treatment:

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