A Phase 2 Study in Patients with Pancreatic Cancer

• Research type

  Research Study

• Full title

  A Randomised Phase 2 Placebo-Controlled Study of LY2495655 in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy

• IRAS ID

  88703

• Contact name

  Kenneth C H Fearon

• Sponsor organisation

  Eli Lilly & Company

• Eudract number

  2011-003822-29

• Research summary

  Pancreatic cancer is currently the fourth highest cause of death from cancer in the western world (Verslype et al. 2007). Survival rates for this disease are poor; where surgical removal is possible, between 5 and 20% of patients will survive to 5 years. In cases where the cancer has advanced and cannot be surgically removed, average patient survival rates are 6 to 11 months. In cases where the disease has spread beyond the tumour site, average survival is only 2 to 6 months. The standard treatment of pancreatic cancer is Gemcitabine, and efforts have been made to improve its efficacy. In patients who have relapsed after first-line gemcitabine therapy, treatment options are limited. No drug is approved in the US or EU for relapsed pancreatic cancer. Many advanced cancer patients suffer with skeletal muscle wasting and higher muscle wasting is associated with poorer survival rates. LY2495655 is a new drug being developed which has the potential to slow or reverse muscle wasting and therefore may improve both quality of life and survival rates in cancer patients. This study aims to evaluate the efficacy of this drug, when used in combination with standard chemotherapy treatment, in improving survival rates in patients with pancreatic cancer. To be eligible to take part in the study patients must be over 18 years of age and have a diagnosis of pancreatic cancer that that is either locally advanced or has spread to another part of the body, and is not currently suitable for surgical treatment. The duration of participation in the study will vary depending on the patient's chemotherapy regime. Study assessments will include CT scan, physical assessments, pulmonary function, and echocardiogram. Self-report questionnaires will be administered measuring quality of life and pain.

• REC name

  Scotland A REC

• REC reference

  12/SS/0007

• Date of REC Opinion

  7 Mar 2012

• REC opinion

  Further Information Favourable Opinion