- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377936
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
November 13, 2008 updated by: MediGene
A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Prague, Czech Republic
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Budapest, Hungary
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Kiev, Ukraine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inoperable adenocarcinoma of the pancreas
- Histologic or cytologic confirmation
- At least 18 years of age
Exclusion Criteria:
- Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
- Major surgery within 4 weeks prior to enrollment
- Major cardiovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 1
Gemcitabine
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Gemcitabine monotherapy 1000 mg/m2 weekly
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Experimental: 2
EndoTag-1 + Gemcitabine
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EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
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Experimental: 3
EndoTag-1 + Gemcitabine
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EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
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Experimental: 4
EndoTag-1 + Gemcitabine
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EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival
Time Frame: Median
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Median
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Progression free survival
Time Frame: Median
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Median
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6-month-survival-rate
Time Frame: 6 Months
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6 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence and percentage of patients with Adverse Events
Time Frame: 28 days after last patient out
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28 days after last patient out
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Number of clinically significant abnormal laboratory values
Time Frame: Last patient out
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Last patient out
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthias Löhr, Prof., Universitätsklinikum Mannheim
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
September 18, 2006
First Submitted That Met QC Criteria
September 18, 2006
First Posted (Estimate)
September 19, 2006
Study Record Updates
Last Update Posted (Estimate)
November 14, 2008
Last Update Submitted That Met QC Criteria
November 13, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
Other Study ID Numbers
- CT4001
- EudraCT No.: 2005-000666-39
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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