Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine
NCT ID: NCT00560963
Last Updated: 2020-12-21
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/PHASE2
21 participants
INTERVENTIONAL
2007-10-31
2011-01-31
Brief Summary
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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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1 RAD001
everolimus
Interventions
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everolimus
Eligibility Criteria
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Inclusion Criteria
2. Adequate bone marrow, liver and renal function on everolimus treatment
3. At least one measurable lesion according to RECIST criteria that has not been previously irradiated.
4. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer.
5. Age \>18 years
Exclusion Criteria
2. Documented intolerance or history of allergy to everolimus or Gemcitabine.
3. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement
5. Chronic treatment with systemic steroids or another immunosuppressive agent
6. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
7. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value \< 50 % or prothrombine time more than 1,5 fold higher
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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Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Merseburg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Oberstaufen, , Germany
Novartis Investigative Site
Ulm, , Germany
Countries
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Related Links
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Results for CRAD001C2491 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CRAD001C2491
Identifier Type: -
Identifier Source: org_study_id