GV1001 And Gemcitabine In Sequential Combination To Gemcitabine Monotherapy In Pancreatic Cancer

Study Overview

GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.

Advanced Unresectable Pancreatic Cancer

BIOLOGICAL: GV1001
DRUG: Gemcitabine (Chemotherapy)

PX115.1.1-302
Eudract no. 2005-005014-21

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-07-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2008-05-16
First Submitted that Met QC Criteria 2006-07-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2008-05-19
First Posted (ESTIMATED) 2006-08-01	Results First Posted N/A	Last Verified 2008-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Gemcitabine Gemcitabine alone treatment.	DRUG: Gemcitabine (Chemotherapy) Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.
EXPERIMENTAL: GV1001 GV1001 in sequential combination with Gemcitabine	BIOLOGICAL: GV1001 0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Gemcitabine

Gemcitabine alone treatment.

DRUG: Gemcitabine (Chemotherapy)

Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.

EXPERIMENTAL: GV1001

GV1001 in sequential combination with Gemcitabine

BIOLOGICAL: GV1001

0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.

Primary Outcome Measures	Measure Description	Time Frame
Overall survival time		12 month

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival		Time of progression

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch
Syneos Health

Investigators

STUDY_DIRECTOR: Ask Aabenhus, MSc. (Pharm), Pharmexa A/S

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

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Clinical Trial Record