Stewart Coats, Andrew J. and Srinivasan, Venkatesan and Surendran, Jayaraman and Chiramana, Haritha and Vangipuram, Shankar R. K. G. and Bhatt, Nirajkumar N. and Jain, Minish and Shah, Sandip and Ali, Irfhan A. B. H. and Fuang, Ho G. and Mat Hassan, Mohd. Zailani and Beadle, John and Tilson, Julia and Kirwan, Bridget-Anne and Anker, Stefan D.
(2011)
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: study design.
Journal of Cachexia, Sarcopenia and Muscle, 2 (4).
pp. 201-207.
ISSN 2190-5991
Abstract
Aims Cachexia, the wasting disorder associated with a wide
range of serious illnesses including cancer, is a major cause of morbidity and mortality. There is currently no widely approved therapeutic agent for treating or preventing
cancer-associated cachexia. Colorectal cancer and nonsmall
cell lung cancer have relatively high incidences of cachexia, approximately 28% and 34%, respectively.
Neurohormonal overactivity has been implicated in the
genesis and progression of cachexia and beta receptor
antagonism has been proposed as a potential therapy.
MT-102, a novel anabolic/catabolic transforming agent,
has a multi-functional effect upon three potential pharmacological targets in cancer cachexia, namely reduced
catabolism through non-selective β-blockade, reduced
fatigue, and thermogenesis through central 5-HT1a
antagonism and increased anabolism through partial β-2
receptor agonism.
Methods At least 132 male and female patients, aged
between 25 and 80 years with a confirmed diagnosis of
late-stage non-small cell lung cancer or colorectal cancer,
with cachexia will be randomised to either one of the two
MT-102 doses or placebo in a 3:1:2 ratio (MT-102
10 mg BD−1/MT-102 2.5 mg BD/placebo). Patients will
continue on study treatment for maximally 16 weeks. The
primary endpoint, to be analysed by assigned treatment
group, will be body weight change over 16 weeks. For this
endpoint, the study has 85% power (0.05% significance
level) to detect per 4-week period a mean change of −0.8 kg
in the placebo group and 0 kg in the high-dose MT-102
arm. The first patient was randomised in February 2011 and
patient recruitment is expected to continue until mid-2012.
Perspective The ACT-ONE trial is designed to test whether
the anabolic/catabolic transforming agent MT-102 will
positively impact on the rate of change of body weight in
cancer cachexia, thereby evaluating a novel therapeutic
strategy in this hitherto poorly treatable condition. A
separate ACT-TWO trial will recruit patients who complete
the ACT-ONE trial and remain on randomised double-blind
medication. Participants in ACT-TWO will be followed for
an additional period with a separate primary endpoint.
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