Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients
Completed · Phase 1
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT01487785
- Run by
- Novartis Pharmaceuticals
- People needed
- 18
- Starts
- 2012-03-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital Dept. of Mass General Hospital — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center MSKCC - SC — New York, New York, United States
- University of Utah / Huntsman Cancer Institute Huntsman UT — Salt Lake City, Utah, United States
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Liverpool, United Kingdom
Full record on ClinicalTrials.gov
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