The ACT-ONE trial, a multicentre, randomised, double-blind, placebo-controlled, dose-finding study of the anabolic/catabolic transforming agent, MT-102 in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer:

• DOI: 10.1007/s13539-011-0046-2
• Publication Date: 2011-10-15T14:01:26Z
• Authors: Andrew J. Stewart...; Venkatesan Sriniv...; Jayaraman Surendran; Haritha Chiramana; Shankar R. K. G. ...; Nirajkumar N. Bhatt; Minish Jain; Sandip Shah; Irfhan A. B. H. Ali; Ho G. Fuang; Mohammed Z. M. Ha...; John Beadle; Julia Tilson; Bridget-Anne Kirwan; Stefan D. Anker
• Keywords: Clinical endpoint

AIMS: Cachexia, the wasting disorder associated with a wide range of serious illnesses including cancer, is major cause morbidity and mortality. There currently no widely approved therapeutic agent for treating or preventing cancer-associated cachexia. Colorectal cancer non-small cell lung have relatively high incidences cachexia, approximately 28% 34%, respectively. Neurohormonal overactivity has been implicated in genesis progression cachexia beta receptor antagonism proposed as potential therapy. MT-102, novel anabolic/catabolic transforming agent, multi-functional effect upon three pharmacological targets namely reduced catabolism through non-selective β-blockade, fatigue, thermogenesis central 5-HT1a increased anabolism partial β-2 agonism. METHODS: At least 132 male female patients, aged between 25 80 years confirmed diagnosis late-stage colorectal will be randomised to either one two MT-102 doses placebo 3:1:2 ratio (MT-102 10 mg BD(-1)/MT-102 2.5 BD/placebo). Patients continue on study treatment maximally 16 weeks. The primary endpoint, analysed by assigned group, body weight change over For this 85% power (0.05% significance level) detect per 4-week period mean -0.8 kg group 0 high-dose arm. first patient was February 2011 recruitment expected until mid-2012. PERSPECTIVE: ACT-ONE trial designed test whether positively impact rate thereby evaluating strategy hitherto poorly treatable condition. A separate ACT-TWO recruit patients who complete remain double-blind medication. Participants followed an additional endpoint.