Back to results

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

Primary Purpose

Adenocarcinoma, Metastasis, Pancreas Neoplasms

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Gemcitabine alone

EndoTAG-1 and Gemcitabine

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring Adenocarcinoma of the pancreas, Locally advanced, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Gemcitabine

EndoTag-1 + Gemcitabine

Outcomes

Primary Outcome Measures

Progression free survival

6-month-survival-rate

Overall survival

Secondary Outcome Measures

Incidence and percentage of patients with Adverse Events

Number of clinically significant abnormal laboratory values

Full Information

NCT ID

NCT00377936

First Posted

September 18, 2006

Last Updated

November 13, 2008

Sponsor

MediGene

1. Study Identification

Unique Protocol Identification Number

NCT00377936

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

MediGene

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma, Metastasis, Pancreas Neoplasms

Keywords

Adenocarcinoma of the pancreas, Locally advanced, Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

212 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Gemcitabine

Arm Title

Arm Type

Experimental

Arm Description

EndoTag-1 + Gemcitabine

Arm Title

Arm Type

Experimental

Arm Description

EndoTag-1 + Gemcitabine

Arm Title

Arm Type

Experimental

Arm Description

EndoTag-1 + Gemcitabine

Intervention Type

Drug

Intervention Name(s)

Gemcitabine alone

Intervention Description

Gemcitabine monotherapy 1000 mg/m2 weekly

Intervention Type

Drug

Intervention Name(s)

EndoTAG-1 and Gemcitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

EndoTAG-1 and Gemcitabine

Intervention Description

EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Intervention Type

Drug

Intervention Name(s)

EndoTAG-1 and Gemcitabine

Intervention Description

EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

Median

Title

6-month-survival-rate

Time Frame

6 Months

Title

Overall survival

Time Frame

Median

Secondary Outcome Measure Information:

Title

Incidence and percentage of patients with Adverse Events

Time Frame

28 days after last patient out

Title

Number of clinically significant abnormal laboratory values

Time Frame

Last patient out

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthias Löhr, Prof.

Organizational Affiliation

Universitätsklinikum Mannheim

Official's Role

Principal Investigator

Facility Information:

City

Prague

Country

Czech Republic

City

Budapest

Country

Hungary

City

Kiev

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs