Viamet Phase I/II Study VMT-VT-464-CL-001

• Research type

  Research Study

• Full title

  A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Chemotherapy-Naïve Patients with Castration-Refractory Prostate Cancer

• IRAS ID

  87168

• Contact name

  Johann de Bono

• Sponsor organisation

  Innocrin Pharmaceuticals, Inc

• Eudract number

  2011-004103-20

• ISRCTN Number

  not known

• Research summary

  This is a Phase 1/2 study which means that it never tested on humans before. In this stage the idea is to find the right dose that will be safe, most beneficial to the patient and with the minimum side effects. The drug called VT-464 will only be tested on patients that never had chemotherapy before.The study consists of 2 phases: a dose-escalation phase (Phase 1) in which we find the right dose, and a cohort-expansion phase (Phase 2) where we test the determined dose. Both Phase 1 and 2 will be divided into 2 stages: a single-dose stage that will last 1 week, and then a repeat-dose stage wherein VT-464 will be taken twice-daily in continuous, 28-day cycles.Each patient, in both Phase 1 and Phase 2, will undergo a Screening period of up to 14 days following the provision of signed informed consent. After completing all study eligibility assessments and determined to be eligible, patients will enter the the Single-Dose stage where they will receive a single assigned dose of VT-464.After one week, patients will then enter the stage 2 stage, a repeat-dose of VT-464 will be taken twice-daily in continuous, 28-day cycles. Throughout the study patients will be required to attend the hospital once a month (apart from cycle 1,3 visits) so they could be monitored for safety by blood and urine samples, ECGs and physical exam. Blood samples will be taken to determine the effect the drug has on the patient. Patients will be monitored for disease progression by measuring their PSA (Prostate Specific Antigen) which is present in the blood of patients with Prostate Cancer, and by radiological assessments when applicable.Patients will stay on study until their disease progresses and they stopped from benefiting from the drug. Patients may withdraw consent at any time.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/1563

• Date of REC Opinion

  13 Oct 2011

• REC opinion

  Favourable Opinion