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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00377936
Other study ID # CT4001
Secondary ID EudraCT No.: 200
Status Completed
Phase Phase 2
First received September 18, 2006
Last updated November 13, 2008
Start date September 2005
Est. completion date October 2008

Study information

Verified date November 2008
Source MediGene
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyUkraine: State Pharmacological Center - Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 212
Est. completion date October 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Gemcitabine alone
Gemcitabine monotherapy 1000 mg/m2 weekly
EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
MediGene

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival Median No
Primary 6-month-survival-rate 6 Months No
Primary Overall survival Median No
Secondary Incidence and percentage of patients with Adverse Events 28 days after last patient out Yes
Secondary Number of clinically significant abnormal laboratory values Last patient out Yes
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