MedDataX Logo

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

NCT00358566 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2008-05-19

No results posted yet for this study

Summary

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

Conditions

  • Advanced Unresectable Pancreatic Cancer

Interventions

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.

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.

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • ORION Clinical Services

    collaborator INDUSTRY

  • CIRION Central Laboratory

    collaborator UNKNOWN

  • Dorevitch

    collaborator UNKNOWN

  • Syneos Health

    collaborator OTHER

  • Pharmexa A/S

    lead INDUSTRY

Principal Investigators

  • Ask Aabenhus, MSc. (Pharm) · Pharmexa A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Denmark
  • France
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden

Study Locations

Related Clinical Trials

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00358566 on ClinicalTrials.gov