Gemcitabine in combination with LDE225 in pancreatic adenocarcinoma

• Research type

  Research Study

• Full title

  A Phase Ib, open-label, multi-center, dose escalation and safety expansion study of Gemcitabine in combination with LDE225 in patients with locally advanced or metastatic pancreatic adenocarcinoma

• IRAS ID

  84511

• Contact name

  Daniel Palmer

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Eudract number

  2010-024218-70

• ISRCTN Number

  n/a

• Research summary

  The primary objective of the study is to determine whether LDE225 in combination with gemcitabine is an effective treatment with patients with pancreatic adenocarcinoma. This is a multicenter, open-label, phase Ib study in adults with locally advanced or metastatic pancreatic adenocarcinoma to determine the Maximun Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) of LDE225 in combination with gemcitabine. The study will be conducted in 2 parts: dose-escalation and safety-expansion part. Dose Escalation Phase: During the dose escalation phase of the study, successive cohorts of newly enrolled patients (a minimum of 3 patients, a maximum of 6 patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily dosing schedule in combination with Intravenous Venous (IV) Gemcitabine on a weekly schedule. Once the MTD is reached the dose expansion phase of the study will open. Once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, and how the body handles and tolerates LDE255 and explore the potential effects of the combined treatments. All patients on the study may continue treatment with LDE225 gemcitabine until disease progression or unacceptable toxicity occurs. The primary objective of the study is to determine whether LDE225 in combination with gemcitabine is an effective treatment with patients with pancreatic adenocarcinoma. This is a multicenter, open-label, phase Ib study in adults with locally advanced or metastatic pancreatic adenocarcinoma to determine the Maximun Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) of LDE225 in combination with gemcitabine. The study will be conducted in 2 parts: dose-escalation and safety-expansion part. Dose Escalation Phase: During the dose escalation phase of the study, successive cohorts of newly enrolled patients (a minimum of 3 patients, a maximum of 6 patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily dosing schedule in combination with Intravenous Venous (IV) Gemcitabine on a weekly schedule. Once the MTD is reached the dose expansion phase of the study will open. Once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, and how the body handles and tolerates LDE255 and explore the potential effects of the combined treatments. All patients on the study may continue treatment with LDE225 gemcitabine until disease progression or unacceptable toxicity occurs.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0401

• Date of REC Opinion

  22 Nov 2011

• REC opinion

  Further Information Favourable Opinion