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A multicentre, randomised, double-blind, placebo-controlled, dose-finding phase II clinical study to evaluate the efficacy of two different doses of MT-102 administered over a sixteen week period in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer

ABSTRACT: Intervention1: MT-102: 1x 2.5mg tablet of MT-102 two times per day 1x 2.5mg tablet of MT-102 + 1 placebo tablet two times per day 1x 2.5mg tablet of MT-102 + 3 placebo tablet two times per day 1 x 2.5mg tablet of MT-102 two times per day 2x 2.5mg tablet of MT-102 two times per day 4 x 2.5mg tablets of MT-102 two times per day Control Intervention1: Placebo: 1x placebo tablet two times per day 2x placebo tablet two times per day 4x placebo tablet two times per day Primary outcome(s): 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 periodTimepoint: Day 7, 14, 21, 28, 56, 84, 112 and 140. Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

DISEASE(S): Patients With Cachexia Related To Stage Iii And Iv Non-small Cell Lung Cancer And Colorectal Cancer

PROVIDER: 2572880 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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