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Metastatic Advanced Pancreas Sorafenib

NCT00758381 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2008-10-10

No results posted yet for this study

Summary

This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.

Conditions

Interventions

DRUG

Sorafenib 400 mg po bid, continuously

NEXAVAR\*112CPR RIV 200MG Titolare AIC: BAYER SpA Numero di AIC dell'IMP: 037154010

DRUG

Gemcitabina, Cisplatino

Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

    lead OTHER

Principal Investigators

  • Stefano Cascinu, M.Professor · GISCAD Foundation

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
2007-08-31
Primary Completion
2008-08-31
Completion
2009-08-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT00758381 on ClinicalTrials.gov