Effect of Anamorelin HCl on Non-Small Cell Lung Cancer - Cachexia

• Research type

  Research Study

• Full title

  Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients with NSCLC-C

• IRAS ID

  79897

• Contact name

  Andreas Polychronis

• Sponsor organisation

  Helsinn Therapeutics (U.S.), Inc.

• Eudract number

  2010-023649-31

• ISRCTN Number

  isrctn

• Research summary

  Anamorelin HCl is an investigational new drug that is being developed to treat cancer cachexia, which is unexpected and rapid involuntary weight loss of lean body mass. The purpose of this study is to evaluate the effect of Anamorelin HCl on lean body mass as measured by DXA scan, on muscle strength as measured by handgrip strength, body weight, quality of life as assessed using the FAACT and FACIT-F questionnaire, overall survival, and to assess the safety and tolerability of Anamorelin HCl. This includes a review of the safety of Anamorelin HCl by a Data Monitoring Company.This study plans to enroll up to 477 patients (males and females) with non-small cell lung cancer, ages 18 and older in up to 40 centres and eight countries worldwide. Eligible patients will be made aware of the study by individual investigators in clinics of the participating institutions.Each patient may remain in the study for as long as 70 weeks. The study will involve up to a total of 7 visits to the research facility. Patients will receive study drug for 12 weeks and then they will have a follow-up visit 4 weeks later. Patients will then be given the option to continue into a 52 week survival period or they may continue into a separate double-blind extension study during which they will receive study drug for an additional 12 weeks.The proposed research has been designed and will be funded by Helsinn Therapeutics (U.S.), Inc.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/1271

• Date of REC Opinion

  13 Oct 2011

• REC opinion

  Further Information Favourable Opinion