Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
NCT ID: NCT00789633
Last Updated: 2018-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
353 participants
INTERVENTIONAL
2008-11-25
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Masitinib
Masitinib at 9 mg/kg/day given orally twice daily
Gemcitabine
Gemcitabine at 1000 mg/m2 by intravenous infusion
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.
Placebo
Matching placebo given orally twice daily
Gemcitabine
Gemcitabine at 1000 mg/m2 by intravenous infusion
Interventions
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Masitinib
Masitinib at 9 mg/kg/day given orally twice daily
Placebo
Matching placebo given orally twice daily
Gemcitabine
Gemcitabine at 1000 mg/m2 by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chemo naïve patients with advanced/metastatic disease
3. Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.
4. Men and women, age \>18 years
5. 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.
6. Patient should be able and willing to comply with study visits and procedures as per protocol.
7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
Exclusion Criteria
2. 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
3. Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline
4. Treatment with any investigational agent within 4 weeks prior to baseline
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Gaël Deplanque, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint Joseph, Paris, France
Locations
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Eastern Connecticut Hematology and Oncology (ECHO)
Norwich, Connecticut, United States
MD Anderson
Orlando, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Medical & Surgical Specialists
Galesburg, Illinois, United States
Berkshire Hematology Oncology
Pittsfield, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Metro MN CCOP
Saint Louis Park, Minnesota, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
The Valley Hospital
Paramus, New Jersey, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Teaching Hospital Brno-Bohunice
Brno, , Czechia
Hospital Chomutov
Chomutov, , Czechia
Oncology Surgery
Kutná Hora, , Czechia
Department of Oncology Teaching Hospital Olomouc
Olomouc, , Czechia
Teaching Hospital Královské
Prague, , Czechia
Teaching Hospital Na Bulovce
Prague, , Czechia
Hospital na Homolce
Prague, , Czechia
CHU Amiens
Amiens, , France
Hôpital Privé d'Antony
Antony, , France
Institut Sainte-Catherine
Avignon, , France
Hôpital Jean Minjoz
Besançon, , France
Hôpital Saint-André
Bordeaux, , France
CHU de la Cavale Blanche
Brest, , France
CHU de Caen
Caen, , France
CHU Hôtel Dieu
Clermont-Ferrand, , France
Groupement Hospitalier Universitaire Nord - Beaujon
Clichy, , France
CHU Henri Mondor
Créteil, , France
CHU Henri Mondor
Créteil, , France
Hôpital Victor Jousselin
Dreux, , France
Centre Gastro-Loire
Gien, , France
Institut Daniel Hollard
Grenoble, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
Hôpital André Mignot
Le Chesnay, , France
Hôpital Robert Boulin
Libourne, , France
Hôpital Claude Huriez
Lille, , France
Centre Hospitalier de Longjumeau
Longjumeau, , France
Hôpital Privé Jean Mermoz
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Centre Léon Bérard
Lyon, , France
Assistance Publique des Hôpitaux de Marseille
Marseille, , France
Hôpital Saint Joseph
Marseille, , France
Centre Hospitalier Belfort - Montbéliard
Montbéliard, , France
CHU Hôtel Dieu
Nantes, , France
Centre Catherine de Sienne
Nantes, , France
Hôpital de la Source
Orléans, , France
Groupe Hospitalier Diaconesse Croix Saint Simon
Paris, , France
Hôpital Tenon
Paris, , France
Hôpital Hôtel Dieu
Paris, , France
Hôpital Saint-Joseph
Paris, , France
Hôpital Haut-Lévêque
Pessac, , France
Polyclinique Francheville
Périgueux, , France
Hôpital Hautepierre
Strasbourg, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Hôpital Paul Brousse
Villejuif, , France
Hotel Dieu de France
Beirut, , Lebanon
Makassed General Hospital Tarik Jadide
Beirut, , Lebanon
Rafik Hariri University Hospital
Beirut, , Lebanon
Saint Georges Hospital UMC
Beirut, , Lebanon
Middle East Institute of Health- Bsaleem
Metn, , Lebanon
Saint Joseph Hospital Baouchrieh
Metn, , Lebanon
Hammoud Hospital University Medical Center
Saida, , Lebanon
Municipal Clinical Hospital
Arad, , Romania
County Hospital
Baia Mare, , Romania
Emergency Clinical Hospital
Constanța, , Romania
Pelica Impex SRL Hospital
Pelica Impex, , Romania
County Hospital
Satu Mare, , Romania
Countries
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References
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Deplanque G, Demarchi M, Hebbar M, Flynn P, Melichar B, Atkins J, Nowara E, Moye L, Piquemal D, Ritter D, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Hammel P. A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer. Ann Oncol. 2015 Jun;26(6):1194-1200. doi: 10.1093/annonc/mdv133. Epub 2015 Apr 9.
Related Links
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Link to article
Other Identifiers
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AB07012
Identifier Type: -
Identifier Source: org_study_id