Clinical Trial: A Clinical Study With MT-102 in Subjects With Cancer Cachexia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate Doses of MT-102 in Subjects With Cachexia Related to Stage III and IV Non-

Brief Summary: A phase II clinical study to evaluate MT-102 administered over a sixteen week period in subjects with cachexia related to non-small cell lung cancer and colorectal cancer

Detailed Summary:

Cachexia is a wasting disease, associated with significant morbidity and mortality, accompanying a wide range of serious illnesses, for which there are currently no widely approved therapeutic agents. Cachexia is defined as weight loss, associated with a chronic underlying disease, of at least 5% in 12 months or less. It is associated with fatigue, loss of muscle strength, a low fat free index and neurohormonal and biochemical abnormalities.

Cancer cachexia occurs in about a third of all patients with cancer and has been estimated to be the direct cause of death in up to 20% of all cancer related deaths. As with other solid tumours, colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) have relatively high incidences of cachexia, approximately 28% and 34% respectively.Through its combined pharmacological actions, MT-102 has a multi-functional effect upon three potential pharmacological targets, each of which is relevant for cancer cachexia

Sponsor: PsiOxus Therapeutics Ltd

Current Primary Outcome: Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer [ Time Frame: 16 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: PsiOxus Therapeutics Ltd

Dates:
Date Received: November 9, 2010
Date Started: April 2011
Date Completion:
Last Updated: September 9, 2014
Last Verified: September 2014