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Brief Title: A Clinical Study With MT-102 in Subjects With Cancer Cachexia
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-small Cell Lung Cancer and Colorectal Cancer
Study ID: NCT01238107
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 Description: 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
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Charite Hospital Virchow-Klinikum Campus, Berlin, , Germany
Kumaran Hospital Private Ltd, Kilpauk, Chennai, India
Dr Kamakshi Memorial Hospital, Pallikaranai, Chennai, India
Vedanta Institute of Medical Science, Ahmedabad, Gujarat, India
Shree Krishna Hopsital, Anand, Gujarat, India
Kailash Cancer Hospital & Research Centre, Goraj, Gujarat, India
TATA Memorial Hopsital, Mumbai, Maharashtra, India
Curie Manavta Cancer Centre, Nashik, Maharashtra, India
Shatabdi Super Speciality Hospital, Nashik, Maharashtra, India
Noble Hopsital, Pune, , India
Hospital Sultahan Bahiyah, Alor Setar, Kedha, Malaysia
Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia
Hospital Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, Malaysia
Universiti Malaya Medical, Jalan Baharu, Kuala Lumpur, Malaysia
Tuanku Ja'afar Hospital, Seremban, Negeri Sembilan, Malaysia
International Islamic University Malaysia, Kuantan, Pahang, Malaysia
Penang General Hopsital, Pulau Pinang, Penang, Malaysia
Hospital Umum Sarawak, Kuching, Sarawak, Malaysia
Name: Kumar n Pradhash, MD
Affiliation: TATA MEMORIAL HOSPITAL , MUMBAI
Role: PRINCIPAL_INVESTIGATOR