Rx of cachexia in advanced lung ca or adenocarcinoma of the pancreas

• Research type

  Research Study

• Full title

  "A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of BYM338 for Treatment of Cachexia in Patients with Stage IV Non-Small Cell Lung Cancer (NSCLC) or Stage III/IV Adenocarcinoma of the Pancreas"

• IRAS ID

  74347

• Sponsor organisation

  Novartis Pharmaceuticals

• Eudract number

  2010-024342-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  Pending

• Research summary

  Lung cancer is the most common cause of cancer death, with more than 1 million new cases recorded each year. Similarly, pancreatic cancer is listed as the fourth most common cause of cancer-related deaths. Patients suffering advanced stages of either disease have a very poor prognosis, confounded by the development of cancer cachexia - the unintentional loss of body mass (body weight and muscle loss), despite adequate dietary intake. Symptoms can significantly affect quality of life by adversely affecting daily motor function (weakness) and ultimately patient prognosis. Muscle wastage is particularly acute in patients who have become bed-ridden due to their disease.Currently, there are no standard treatments specifically available for treating cancer cachexia.BYM338 is an investigational drug being tested to determine whether or not it can reverse the effects of muscle wastage by stimulating muscle development and growth and improving muscle strength. This is a multicentre study conducted across 10-15 international sites. The purpose is to assess the preliminary efficacy of BYM338 for treating cancer cachexia in adult patients with stage IV non-small cell lung adenocarcinoma or stage III/IV pancreatic adenocarcinoma, assessed in terms of an increase of muscle volume and function. Results will also provide information on the safety, tolerability, pharmacokinetics and pharmacodynamic (PD) responses to BYM338 in the study population.The study will be conducted in three parts: Core study (8 weeks), follow-up phase (optional) (8 weeks) and vital status phase (8 weeks).

• REC name

  Scotland A REC

• REC reference

  11/AL/0365

• Date of REC Opinion

  27 Jun 2011

• REC opinion

  Favourable Opinion