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Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04).


ABSTRACT: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia.This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non-small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100?mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results.The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38?±?0.18 and -0.17?±?0.17?kg in the anamorelin and placebo groups, respectively (P?

SUBMITTER: Katakami N 

PROVIDER: S-EPMC5814824 | biostudies-other | 2018 Feb

REPOSITORIES: biostudies-other

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Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04).

Katakami Nobuyuki N   Uchino Junji J   Yokoyama Takuma T   Naito Tateaki T   Kondo Masashi M   Yamada Kouzo K   Kitajima Hiromoto H   Yoshimori Kozo K   Sato Kazuhiro K   Saito Hiroshi H   Aoe Keisuke K   Tsuji Tetsuya T   Takiguchi Yuichi Y   Takayama Koichi K   Komura Naoyuki N   Takiguchi Toru T   Eguchi Kenji K  

Cancer 20171204 3


<h4>Background</h4>Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia.<h4>Methods</h4>This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non-small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized  ...[more]

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