A Study to Evaluate Once-Daily Oral VT-464 in Patients Wi... | NCT02361086

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regimen 1: 7dayPM+DT	Experimental	VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week with a 2-week dose titration.	Drug: VT-464: given orally once daily in 28 day cycles
Regimen 2: 7dayPM-DT	Experimental	VT-464: given orally once daily in 28 day cycles. Dosing in the evening before bed 7-days a week without dose titration.	Drug: VT-464: given orally once daily in 28 day cycles
Regimen 3: 7dayAM+DT	Experimental	VT-464: given orally once daily in 28 day cycles. Dosing in the morning 7-days a week with a 2-week dose titration.	Drug: VT-464: given orally once daily in 28 day cycles
Regimen 4: 7dayAM-DT	Experimental	VT-464: given orally once daily in 28 day cycles.Dosing in the morning 7-days a week without dose titration.	Drug: VT-464: given orally once daily in 28 day cycles
Regimen 5: 5dayPM-DT	Experimental	VT-464: given orally once daily in 28 day cycles.Dosing in the evening before bed 5-days a week without dose titration.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VT-464: given orally once daily in 28 day cycles	Drug	VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.	Regimen 1: 7dayPM+DT Regimen 2: 7dayPM-DT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The safety and tolerability of VT-464 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.		The first 28-day continuous dosing cycle at target dose.

Secondary Outcomes

Measure	Description	Time Frame
Peak Plasma Concentration (Cmax) of VT-464		After the first dose of VT-464
Area under the plasma concentration versus time curve (AUC) of VT-464		After the first dose of VT-464

Other Outcomes

Measure	Description	Time Frame
The change in PSA from baseline using waterfall plots in response to VT-464		At least monthly over the first 8 28-day dosing cycles
Objective tumor response to VT-464 at the end of even-numbered cycles using RECIST 1.1 criteria		At least every other month over the first 8 28-day dosing cycles

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
Patients must have a minimum serum PSA level of >2 ng/ml that is rising based on the Prostate Cancer Working Group 2 criteria.
Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]).
Patients must have undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study entry. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
Patients must have an ECOG Performance Score of 0 or 1.

Key Exclusion Criteria:

Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
Patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
Patients who have completed sipuleucel-T (Provenge ®) treatment within 30 days of study entry.
Patients who have received TOK-001 (Galeterone®) or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for > 3 months must be off treatment for 6 weeks and demonstrate a continued rise in PSA after withdrawal. Patients on antiandrogens for < 3 months must be off medication for 2 weeks. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) must stop medication at least 3 months from study entry.
Patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
Patients who have received palliative radiotherapy within 4 weeks of study entry.
Patients with a history within the last 3 years of another invasive malignancy.

Facility	Status	City	State	ZIP	Country	Contacts
H. Lee Moffitt Cancer Center and Research Institute		Tampa	Florida	33612	United States
Urology Cancer Center