Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients
NCT ID: NCT01487785
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2012-03-31
2014-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LDE225+gemcitabine
Increasing doses of LDE225 (from 400 mg) once a day + 1000 mg/m2 of gemcitabine on days 1, 8 and 15 of every 28 day cycle.
LDE225+gemcitabine
Patients will receive increasing doses of LDE225 (from 400 mg), depending on the cohort they are assigned to, orally once daily and standard doses of gemcitabine (1000 mg/m2) on days 1, 8 and 15 of every 28-day cycle. Patients will receive the study treatment until they progressed, experience unacceptable toxicity, withdraw from the study, or the investigator decides it is in their best interest to discontinue the study treatment.
Interventions
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LDE225+gemcitabine
Patients will receive increasing doses of LDE225 (from 400 mg), depending on the cohort they are assigned to, orally once daily and standard doses of gemcitabine (1000 mg/m2) on days 1, 8 and 15 of every 28-day cycle. Patients will receive the study treatment until they progressed, experience unacceptable toxicity, withdraw from the study, or the investigator decides it is in their best interest to discontinue the study treatment.
Eligibility Criteria
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Inclusion Criteria
* Performance status of 0 or 1 per WHO classification
* Adequate hematologic , renal and liver function
* Adequate blood creatine kinase value (CK \< 1.5ULN)
Exclusion Criteria
* Pancreatic cancer that is potentially curable by surgery
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Related Links
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Results for CLDE225X2103 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2010-024218-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLDE225X2103
Identifier Type: -
Identifier Source: org_study_id