LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor: Massachusetts General Hospital
Study ID: NCT01485744
Phase: PHASE1
Status: Completed

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - 72 Years
Healthy Volunteers: Not accepted

Interventions

LDE225; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan — DRUG
LDE225 200-800 mg daily orally. Fluorouracil 2400 mg IV every other week. Irinotecan 180 mg/m2 IV every other week. Oxaliplatin 85 mg/m2 IV every other week. Leucovorin 400 mg/m2 IV every other week.

Study Details

LDE225 is a new medicine that blocks the Hedgehog (Hh) pathway. The Hh pathway is a cascade of molecular events that control cell growth and have been linked with the development of many human cancers, including pancreatic cancer. Information from research studies suggests that LDE225 in combination with FOLFIRINOX may help to stop the growth of cancer cells. In this research study, the investigators are looking to determine the maximum dose of LDE225 in combination that can be given safely to patients with locally advanced or metastatic pancreatic cancer.