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Completed

NCT Number: NCT00377936

EndoTAG-1 / Gemcitabine Combination Therapy to Treat 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.

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Key information

Conditions

Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pancreas Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prague, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine alone

Drug

Gemcitabine monotherapy 1000 mg/m2 weekly

EndoTAG-1 and Gemcitabine

Drug

EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Primary outcomes

  1. Progression free survival

    Time frame: Median

  2. 6-month-survival-rate

    Time frame: 6 Months

  3. Overall survival

    Time frame: Median

Secondary outcomes

  1. Incidence and percentage of patients with Adverse Events

    Time frame: 28 days after last patient out

  2. Number of clinically significant abnormal laboratory values

    Time frame: Last patient out

Sponsors and collaborators

Lead sponsor

MediGene

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2006
Registry last updated
Nov 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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