Status:
COMPLETED
LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-72 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Study medication will be given in cycles of 14 days. Subjects will keep a study drug diary for each treatment cycle. LDE225 capsules will be taken by mouth in the morning every day of each cycle. On ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma
- Previously untreated locally advanced or metastatic pancreatic adenocarcinoma. Pts newly diagnosed with metastatic recurrence after adjuvant therapy for resected disease are eligible, if completion of adjuvant therapy was \> 8 months ago
- Measurable disease
- Adequate organ and marrow function
- Able to take oral drugs
Exclusion
- Concurrent active primary or metastatic cancer other than superficial squamous cell or basal cell skin cancer
- Pregnant or breastfeeding
- Receiving any other standard or investigation anticancer agents, with the exception of hormonal therapy
- Prior chemoradiation to the primary pancreatic tumor unless there is a measurable distant site of disease
- Known CNS metastases
- History of hypersensitivity reactions to any components of the treatment regimen
- Known malabsorption syndromes
- Neuromuscular disorders
- Receiving other anti-neoplastic therapy concurrently
- Requires warfarin/Coumadin for therapeutic coagulation
- Receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5
- Uncontrolled diarrhea
- Peripheral neuropathy \> grade 1 due to any cause
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV positive
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01485744
Start Date
December 1 2011
End Date
November 1 2019
Last Update
August 4 2020
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02214