Status:
COMPLETED
Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy
- Performance status of 0 or 1 per WHO classification
- Adequate hematologic , renal and liver function
- Adequate blood creatine kinase value (CK \< 1.5ULN)
Exclusion
- Treatment with prior radiotherapy
- Pancreatic cancer that is potentially curable by surgery
- Women of childbearing potential unless they are using highly effective method of contraception Other protocol-defined inclusion/exclusion criteria may apply
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01487785
Start Date
March 1 2012
End Date
July 1 2014
Last Update
December 19 2020
Active Locations (5)
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1
Massachusetts General Hospital Dept. of Mass General Hospital
Boston, Massachusetts, United States, 02114
2
Memorial Sloan Kettering Cancer Center MSKCC - SC
New York, New York, United States, 10021
3
University of Utah / Huntsman Cancer Institute Huntsman UT
Salt Lake City, Utah, United States, 84103
4
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08035