FDAnews
www.fdanews.com/articles/73243-peregrine-opens-patient-enrollment-for-tarvacin-solid-cancer-therapy-trial

Peregrine Opens Patient Enrollment for Tarvacin Solid Cancer Therapy Trial

June 10, 2005

Peregrine Pharmaceuticals, has initiated its Tarvacin Phase I cancer therapy clinical trial.

The clinical trial is open to patients with any advanced refractory solid tumor malignancy. The initial clinical centers open for patient enrollment are the Scottsdale and Tucson sites of the Arizona Cancer Center. The clinical trial is designed to enroll up to 28 patients with advanced solid tumors that no longer respond to standard cancer treatments.

The objectives of this open-label dose escalation study are to (i) determine the safety and tolerability of Tarvacin administered intravenously to patients with advanced cancer; (ii) characterize the pharmacokinetic profile of Tarvacin and; (iii) define the dose-limiting toxicities, maximum-tolerated dose and/or maximum effective dose of Tarvacin. Patients who demonstrate an objective response to therapy may be offered continued treatment on an extension protocol.