- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00789633
Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
December 13, 2018 updated by: AB Science
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth factors receptors and ligands, including expression of both PDGF and PDGF receptors.
Drugs that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer.
Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases.
Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine.
Based on pre-clinical and phase 2 clinical studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.
Study Type
Interventional
Enrollment (Actual)
353
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brno, Czechia, 625 00
- Teaching Hospital Brno-Bohunice
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Chomutov, Czechia, 430 12
- Hospital Chomutov
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Kutná Hora, Czechia, 284 30
- Oncology Surgery
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Olomouc, Czechia, 775 20
- Department of Oncology Teaching Hospital Olomouc
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Prague, Czechia, 5 150 30
- Hospital Na Homolce
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Prague 10, Czechia, 100 34
- Teaching Hospital Královské
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Prague 8, Czechia, 180 81
- Teaching Hospital Na Bulovce
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Amiens, France, 80000
- CHU Amiens
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Antony, France, 92160
- Hôpital Privé d'Antony
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Avignon, France, 84000
- Institut Sainte-Catherine
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Besançon, France
- Hôpital Jean Minjoz
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Bordeaux, France
- Hopital Saint-Andre
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Brest, France, 29600
- CHU de la Cavale Blanche
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Caen, France, 14000
- CHU de Caen
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Clermont-Ferrand, France, 63000
- CHU Hotel Dieu
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Clichy, France, 92
- Groupement Hospitalier Universitaire Nord - Beaujon
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Créteil, France
- CHU Henri Mondor
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Créteil, France, 94000
- CHU Henri Mondor
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Dreux, France
- Hopital Victor Jousselin
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Gien, France, 45500
- Centre Gastro-Loire
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Grenoble, France, 38000
- Institut Daniel Hollard
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La Roche sur Yon, France, 85925
- CHD Les Oudairies
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Le Chesnay, France, 78150
- Hopital Andre Mignot
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Libourne, France, 33500
- Hôpital Robert Boulin
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Lille, France, 59000
- Hopital Claude Huriez
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Longjumeau, France, 91164
- Centre Hospitalier de Longjumeau
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Lyon, France, 69003
- Hôpital Edouard Herriot
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Lyon, France
- Centre Léon Berard
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Lyon, France, 69000
- Hopital Prive Jean Mermoz
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Marseille, France, 13000
- Assistance Publique Des Hopitaux de Marseille
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Marseille, France, 13000
- Hopital Saint Joseph
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Montbeliard, France, 25200
- Centre Hospitalier Belfort - Montbéliard
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Nantes, France, 44200
- Centre Catherine De Sienne
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Nantes, France, 44000
- CHU Hotel Dieu
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Orléans, France, 45000
- Hôpital de la Source
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Paris, France, 75020
- Hopital Tenon
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Paris, France
- Hôpital Saint-Joseph
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Paris, France, 75000
- Groupe Hospitalier Diaconesse Croix Saint Simon
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Paris, France
- Hôpital Hotel Dieu
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Perigueux, France, 24000
- Polyclinique Francheville
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Pessac, France, 33600
- Hôpital Haut-Lévêque
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Strasbourg, France, 67200
- Hôpital Hautepierre
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Vandoeuvre lès Nancy, France, 54500
- Chu Brabois
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Villejuif, France, 94800
- Hôpital Paul Brousse
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Beirut, Lebanon
- Rafik Hariri University Hospital
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Beirut, Lebanon
- Hotel Dieu de France
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Beirut, Lebanon
- Makassed General Hospital Tarik Jadide
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Beirut, Lebanon
- Saint Georges Hospital UMC
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Metn, Lebanon
- Middle East Institute of Health- Bsaleem
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Metn, Lebanon
- Saint Joseph Hospital Baouchrieh
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Saida, Lebanon
- Hammoud Hospital University Medical Center
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Arad, Romania, 310013
- Municipal Clinical Hospital
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Baia-Mare, Romania, 430031
- County Hospital
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Constanta, Romania, 900591
- Emergency Clinical Hospital
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Pelica Impex, Romania, 410548
- Pelica Impex SRL Hospital
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Satu Mare, Romania, 440056
- County Hospital
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Connecticut
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Norwich, Connecticut, United States, 06360
- Eastern Connecticut Hematology and Oncology (ECHO)
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Florida
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Orlando, Florida, United States, 32806
- MD Anderson
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Georgia
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Atlanta, Georgia, United States, 30322
- The Emory Clinic
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Illinois
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Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
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Galesburg, Illinois, United States, 61401
- Medical & Surgical Specialists
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Massachusetts
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Pittsfield, Massachusetts, United States, 01201
- Berkshire Hematology Oncology
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Minnesota
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Saint Louis Park, Minnesota, United States, 55416
- Metro MN CCOP
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Missouri
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Kansas City, Missouri, United States, 64111
- Saint Luke's Cancer Institute
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New Jersey
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Paramus, New Jersey, United States, 07652
- The Valley Hospital
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North Carolina
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Goldsboro, North Carolina, United States, 27534
- Southeastern Medical Oncology Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Chemo naïve patients with advanced/metastatic disease
- Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.
- Men and women, age >18 years
- Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
- Patient should be able and willing to comply with study visits and procedures as per protocol.
- Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
Main Exclusion Criteria:
- Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or in situ cervical cancer
- Any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
- Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline
- Treatment with any investigational agent within 4 weeks prior to baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Masitinib & gemcitabine
Participants receive masitinib (9 mg/kg/day), given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest.
Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.
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Masitinib at 9 mg/kg/day given orally twice daily
Other Names:
Gemcitabine at 1000 mg/m2 by intravenous infusion
Other Names:
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PLACEBO_COMPARATOR: Placebo & gemcitabine
Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest.
Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.
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Gemcitabine at 1000 mg/m2 by intravenous infusion
Other Names:
Matching placebo given orally twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: From day of randomization to the date of death, assessed up to 60 months
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Overall survival is defined as time in months from the randomization date to the date of death due to any cause.
If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
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From day of randomization to the date of death, assessed up to 60 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate
Time Frame: Every 24 weeks, assessed up to 60 months
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Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.
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Every 24 weeks, assessed up to 60 months
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Progression Free Survival (PFS)
Time Frame: From day of randomization to disease progression or death, whichever came first, assessed up to 60 months
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Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy.
Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria.
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From day of randomization to disease progression or death, whichever came first, assessed up to 60 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gaël Deplanque, MD, Hôpital Saint Joseph, Paris, France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start (ACTUAL)
November 25, 2008
Primary Completion (ACTUAL)
December 23, 2011
Study Completion (ACTUAL)
August 31, 2012
Study Registration Dates
First Submitted
November 12, 2008
First Submitted That Met QC Criteria
November 12, 2008
First Posted (ESTIMATE)
November 13, 2008
Study Record Updates
Last Update Posted (ACTUAL)
December 17, 2018
Last Update Submitted That Met QC Criteria
December 13, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- AB07012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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