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COMPLETEDPHASE3

Masitinib Plus Gemcitabine in Pancreatic Cancer

A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer

NCT03766295•AB Science

View on ClinicalTrials.gov

Summary

The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.

Detailed Description

Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine with respect to placebo in combination with gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic cancer patients with pain related to the disease. Approximately 330 patients with pain Visual Analogue Scale (VAS) \> 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively. The primary outcome measure is overall survival (OS).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage
•2. Patient with pain related to the disease, as assessed by the investigator and the patient:
•* Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline.
•* Pain, as assessed by the patient is defined as at least one value out of two values \> 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value).
•OR
•\- Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).
•3\. Chemotherapy naïve patient for the advanced/metastatic disease

Exclusion Criteria

•1. Patient with no pain related to the disease (as defined in the inclusion criterion number 2)
•2. Pregnant or nursing female patient

Locations (9)

Hospital AZ Sint-Jan

Bruges, Belgium

Polyclinique de Limoges site CHENIEUX

Limoges, France

Centre Hospitalier de Longjumeau

Longjumeau, France

General University Hospital of Patras

Pátrai, Greece

Sanjeevani CBCC USA Cancer Hospital

Raipur, India

Omsk Clinical oncology dispensary Omsk

Omsk, Russia

National Oncology Institute

Bratislava, Slovakia

Institut Salah Azaiez de Cancerologie

Bab Saadoun, Tunisia

Center of Surgical Innovations

Kiev, Ukraine

Key Dates

Start Date

July 1, 2014

Primary Completion Date

December 1, 2020

Completion Date

December 1, 2020

Last Updated

December 8, 2020

Enrollment

377

ACTUAL participants

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Interventions

Masitinib

DRUG

Gemcitabine

DRUG

Placebo

DRUG

Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer

NCT03579836

Locally Advanced or Metastatic Pancreatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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