Everolimus alone or with Pasireotide LAR in pancreatic cancer.

• Research type

  Research Study

• Full title

  A randomized, open-label phase II multicenter study evaluating the efficacy of oral Everolimus alone or in combination with Pasireotide LAR i.m. in advanced progressive pancreatic neuroendocrine tumors (PNET) – The COOPERATE-2 study.

• IRAS ID

  76827

• Contact name

  Juan W Valle

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-023183-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This trial will evaluate the efficacy and safety of everolimus alone and in combination with pasireotide LAR in patients with pathologically confirmed advanced (unresectable or metastatic) low to intermediate-grade Pancreatic Neuroendocrine Tumours. Assessment of efficacy will be based on local blinded radiology evaluation of CT/MRI scans according to RECIST. In addition, specific biomarkers for known and suspected pathways involved in secretion, viability, proliferation and angiogenesis will be explored. Approximately 150 patients will be randomised globally.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0116

• Date of REC Opinion

  28 Jun 2011

• REC opinion

  Further Information Favourable Opinion