Date: 2014-10-06
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Foamix Pharmaceuticals (Israel - USA - NJ)
Product: FDX104 (topical formulation of doxycycline)
Action mechanism:
Disease: prevention of rash in cancer patients taking epidermal growth factor receptor inhibitors (EGFRI)
Therapeutic area: Cancer - Oncology - Dermatological diseases
Country: Israel
Trial
details: The trial is a phase II multicenter, randomized, double blind, vehicle controlled clinical study to evaluate the safety, tolerability and efficacy of FDX104 administered topically for prevention of EGFRI related skin toxicity in 24 cancer patients. There is an initial screening period, 5 weeks of treatment, and a post-treatment follow up visit 4 weeks later. Approximately seven days after randomization and study drug initiation, patients will start their EGFRI treatment. The primary objective is to demonstrate the safety and tolerability of FDX104 adjunct to either Erbitux or Vectibix treatment. Safety and tolerability will be evaluated by measurements of vital signs, incidence and severity of adverse events and evaluation of skin tolerability. The trial is being conducted in Israel.
Latest
news: * On October 6, 2014, Foamix Pharmaceuticals, a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced the initiation of a Phase II trial with FDX104, its topical formulation of doxycycline, to prevent rash in cancer patients taking epidermal growth factor receptor inhibitors (EGFRI). Between 45% and 100% of patients receiving EGFRI drugs, such as Erbitux® (cetuximab) and Vectibix® (panitumumab) are currently affected by severe acne-like rashes.
