EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
NCT ID: NCT00377936
Last Updated: 2008-11-14
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
PHASE2
212 participants
INTERVENTIONAL
2005-09-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Gemcitabine
Gemcitabine alone
Gemcitabine monotherapy 1000 mg/m2 weekly
2
EndoTag-1 + Gemcitabine
EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
3
EndoTag-1 + Gemcitabine
EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
4
EndoTag-1 + Gemcitabine
EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Interventions
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Gemcitabine alone
Gemcitabine monotherapy 1000 mg/m2 weekly
EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Eligibility Criteria
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Inclusion Criteria
* Histologic or cytologic confirmation
* At least 18 years of age
Exclusion Criteria
* Major surgery within 4 weeks prior to enrollment
* Major cardiovascular disease
18 Years
ALL
No
Sponsors
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MediGene
INDUSTRY
Responsible Party
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MediGene
Principal Investigators
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Matthias Löhr, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Mannheim
Locations
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Prague, , Czechia
Budapest, , Hungary
Kiev, , Ukraine
Countries
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Other Identifiers
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EudraCT No.: 2005-000666-39
Identifier Type: -
Identifier Source: secondary_id
CT4001
Identifier Type: -
Identifier Source: org_study_id
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