Phase 3 oral talactoferrin non-small cell lung cancer
Research type
Research Study
Full title
FORTIS-M: A Phase 3, randomized, double blind, placebo-controlled, study of oral talactoferrin in addition to best supportive care in patients with non-small cell lung cancer who have failed two or more treatment regimens
IRAS ID
28122
Contact name
Yvonne Summers
Sponsor organisation
Agennix Incorporated
Eudract number
2009-012709-20
Clinicaltrials.gov Identifier
Research summary
This is a double-blind, placebo-controlled, multicenter, Phase 3 study for adult patients with advanced or metastatic non-small cell lung cancer who have failed two or more prior treatment regimens. Approximately 720 patients will receive best supportive care (not including any anti-cancer therapy) and be randomly assigned at a ratio of 2:1 to Talactoferrin (arm 1) or placebo (arm 2). The main objective is to determine the safety and the efficacy of Talactoferrin on overall survival. During the trial the suitable subjects are to receive Talactoferrin or placebo for a maximum of five cycles. Each cycle includes 12 weeks on study drug and 2 weeks off study drug. Talactoferrin or placebo is taken twice a day orally. The planned duration of the subjects?? participation is approximately 18 months.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
09/H0408/95
Date of REC Opinion
16 Nov 2009
REC opinion
Further Information Favourable Opinion