Date: 2015-01-12
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Novocure (UK)
Product: Tumor Treating Fields (TTFields) together with gemcitabine
Action
mechanism: Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates a low intensity, alternating electric fields within a tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
Disease: newly-diagnosed advanced pancreatic adenocarcinoma
Therapeutic area: Cancer - Oncology
Country: Germany, Spain, Switzerland
Trial
details: PANOVA is an open-label phase II clinical trial designed to test the safety and preliminary efficacy of TTFields therapy together with gemcitabine for the first line treatment of pancreatic adenocarcinoma (NCT01971281). Following regulatory approval, PANOVA will enroll an additional cohort of twenty patients in Spain, Germany and Switzerland investigating TTFields in combination with gemcitabine and nab-paclitaxel.
Latest
news: * On January 12, 2015, Novocure, a commercial stage oncology company, announced that the last patient has been enrolled in the PANOVA trial, an open-label phase II clinical trial of Tumor Treating Fields (TTFields) together with gemcitabine in twenty patients with newly-diagnosed advanced pancreatic adenocarcinoma. In light of the rapid conclusion of enrollment, the absence of serious safety concerns, to date, and following a request by study physicians, Novocure will expand the trial to include an additional study cohort of twenty patients who will be treated with concomitant TTFields, gemcitabine and nab-paclitaxel.
