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Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

NCT00789633 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2018-12-17

No results posted yet for this study

Summary

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.

Conditions

Interventions

DRUG

Masitinib

Masitinib at 9 mg/kg/day given orally twice daily

DRUG

Placebo

Matching placebo given orally twice daily

DRUG

Gemcitabine

Gemcitabine at 1000 mg/m2 by intravenous infusion

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Gaël Deplanque, MD · Hôpital Saint Joseph, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-25
Primary Completion
2011-12-23
Completion
2012-08-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Lebanon
  • Romania

Study Locations

More Related Trials

Entities

Drugs
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 NCT00789633 on ClinicalTrials.gov