Anamorelin HCl effect on Non-Small Cell Lung Cancer-Cachexia Extension

• Research type

  Research Study

• Full title

  Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): An Extension Study

• IRAS ID

  82568

• Contact name

  Andreas Polychronis

• Sponsor organisation

  Helsinn Therapeutics (U.S.), Inc.

• Eudract number

  2010-023650-36

• ISRCTN Number

  isrctn

• Research summary

  Anamorelin HCl is an investigational new drug that's being developed to treat cancer cachexia, which is unexpected and rapid involuntary weight loss of lean body mass. The purpose of this extension study is to evaluate how safe and tolerable Anamorelin HCl is when taken for more than 12 weeks and up to 24 weeks. In addition, the study will also assess the effect of Anamorelin HCl to see if it improves strength, results in body weight gain and quality of life improves. This study plans to enroll up to 350 patients (males and females) with non-small cell lung cancer, ages 18 and older in up to 95 centres and fourteen 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 17 weeks. The study will involve up to a total of 6 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. 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/1272

• Date of REC Opinion

  13 Oct 2011

• REC opinion

  Further Information Favourable Opinion