EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
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ClinicalTrials.gov Identifier: NCT00377936 |
Recruitment Status :
Completed
First Posted : September 19, 2006
Last Update Posted : November 14, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma Metastasis Pancreas Neoplasms | Drug: Gemcitabine alone Drug: EndoTAG-1 and Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 212 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Gemcitabine
|
Drug: Gemcitabine alone
Gemcitabine monotherapy 1000 mg/m2 weekly |
Experimental: 2
EndoTag-1 + Gemcitabine
|
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly |
Experimental: 3
EndoTag-1 + Gemcitabine
|
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly |
Experimental: 4
EndoTag-1 + Gemcitabine
|
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly |
- Progression free survival [ Time Frame: Median ]
- 6-month-survival-rate [ Time Frame: 6 Months ]
- Overall survival [ Time Frame: Median ]
- Incidence and percentage of patients with Adverse Events [ Time Frame: 28 days after last patient out ]
- Number of clinically significant abnormal laboratory values [ Time Frame: Last patient out ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377936
Czech Republic | |
Prague, Czech Republic | |
Hungary | |
Budapest, Hungary | |
Ukraine | |
Kiev, Ukraine |
Principal Investigator: | Matthias Löhr, Prof. | Universitätsklinikum Mannheim |
Responsible Party: | Susanne Kienzle-Horn / Clinical Trial Manager, MediGene |
ClinicalTrials.gov Identifier: | NCT00377936 |
Other Study ID Numbers: |
CT4001 EudraCT No.: 2005-000666-39 |
First Posted: | September 19, 2006 Key Record Dates |
Last Update Posted: | November 14, 2008 |
Last Verified: | November 2008 |
Adenocarcinoma of the pancreas Locally advanced Metastatic |
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Paclitaxel |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |