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

MediGene

Status and phase: Completed; Phase 2

Conditions: Metastasis; Adenocarcinoma; Pancreas Neoplasms

Treatments: Drug: Gemcitabine alone; Drug: EndoTAG-1 and Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377936

EudraCT No.: 2005-000666-39

CT4001

Details and patient eligibility

About

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

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 4 patient groups

1

Active Comparator group

Description:

Gemcitabine

Treatment:

Drug: Gemcitabine alone

2

Experimental group

Description:

EndoTag-1 + Gemcitabine

Treatment:

Drug: EndoTAG-1 and Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

3

Experimental group

Description:

EndoTag-1 + Gemcitabine

Treatment:

Drug: EndoTAG-1 and Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

4

Experimental group

Description:

EndoTag-1 + Gemcitabine

Treatment:

Drug: EndoTAG-1 and Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

Drug: EndoTAG-1 and Gemcitabine