Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
NCT ID: NCT00681798
Last Updated: 2016-08-29
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
8 participants
INTERVENTIONAL
2006-07-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose level 1
Vandetanib 100mg/day plus Gemcitabine
Vandetanib
100mg/300mg
Dose level 2
Vandetanib 300mg/day plus Gemcitabine
Vandetanib
100mg/300mg
Dose level 3
Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
Vandetanib
100mg/300mg
Dose level 4
Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
Vandetanib
100mg/300mg
Interventions
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Vandetanib
100mg/300mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status \<1
* Measurable disease
Exclusion Criteria
* Clinically significant cardiac event such as myocardial infarction
* Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Research Site
Sankt Gallen, Canton of St. Gallen, Switzerland
Research Site
Bellinzona, , Switzerland
Countries
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References
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Saletti P, Sessa C, De Dosso S, Cerny T, Renggli V, Koeberle D. Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma. Oncology. 2011;81(1):50-4. doi: 10.1159/000330769. Epub 2011 Sep 15.
Related Links
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Other Identifiers
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D4200L00003
Identifier Type: -
Identifier Source: org_study_id
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