NCT00377936

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Typical duration for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 14, 2008

Status Verified

November 1, 2008

Enrollment Period

2.8 years

First QC Date

September 18, 2006

Last Update Submit

November 13, 2008

Conditions

AdenocarcinomaMetastasisPancreas Neoplasms

Keywords

Adenocarcinoma of the pancreasLocally advancedMetastatic

Outcome Measures

Primary Outcomes (3)

  • Progression free survival

    Median

  • 6-month-survival-rate

    6 Months

  • Overall survival

    Median

Secondary Outcomes (2)

  • Incidence and percentage of patients with Adverse Events

    28 days after last patient out

  • Number of clinically significant abnormal laboratory values

    Last patient out

Study Arms (4)

1

ACTIVE COMPARATOR

Gemcitabine

Drug: Gemcitabine alone

2

EXPERIMENTAL

EndoTag-1 + Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

3

EXPERIMENTAL

EndoTag-1 + Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

4

EXPERIMENTAL

EndoTag-1 + Gemcitabine

Drug: EndoTAG-1 and Gemcitabine

Interventions

Gemcitabine aloneDRUG

Gemcitabine monotherapy 1000 mg/m2 weekly

1
EndoTAG-1 and GemcitabineDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Kiev, Ukraine

Location

MeSH Terms

Conditions

AdenocarcinomaNeoplasm MetastasisPancreatic Neoplasms

Interventions

GemcitabineMBT-0206

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Matthias Löhr, Prof.

    Universitätsklinikum Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

November 14, 2008

Record last verified: 2008-11

Locations

CZ(1)HU(1)UA(1)