Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This phase Ib study includes two phases: dose escalation phase and safety expansion phase.
During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and
maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225
administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase
of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for
expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or
metastatic pancreatic adenocarcinoma patients.
During the safety expansion phase, 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, tolerability and explore the potential efficacy of the combined
treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.