EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

Phase 2

Completed

• Conditions: Adenocarcinoma; Metastasis; Pancreas Neoplasms
• Interventions: Drug: Gemcitabine alone; Drug: EndoTAG-1 and Gemcitabine

• Registration Number: NCT00377936
• Lead Sponsor: MediGene

Brief Summary

The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-18
• Study First Posted: 2006-09-19
• Primary Completion: 2008-06
• Study Completion: 2008-10
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-13
• Last Update Posted: 2008-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• Inoperable adenocarcinoma of the pancreas
• Histologic or cytologic confirmation
• At least 18 years of age

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Exclusion Criteria

• Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
• Major surgery within 4 weeks prior to enrollment
• Major cardiovascular disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gemcitabine alone	Gemcitabine
2	EndoTAG-1 and Gemcitabine	EndoTag-1 + Gemcitabine
3	EndoTAG-1 and Gemcitabine	EndoTag-1 + Gemcitabine
4	EndoTAG-1 and Gemcitabine	EndoTag-1 + Gemcitabine

Primary Outcome Measures

Name	Time	Method
Progression free survival	Median
6-month-survival-rate	6 Months
Overall survival	Median

Secondary Outcome Measures

Name	Time	Method
Incidence and percentage of patients with Adverse Events	28 days after last patient out
Number of clinically significant abnormal laboratory values	Last patient out