Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
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
1 other identifier
interventional
353
5 countries
68
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pancreatic-cancer
Started Nov 2008
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedStudy Start
First participant enrolled
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2012
CompletedDecember 17, 2018
December 1, 2018
3.1 years
November 12, 2008
December 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
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.
From day of randomization to the date of death, assessed up to 60 months
Secondary Outcomes (2)
Survival rate
Every 24 weeks, assessed up to 60 months
Progression Free Survival (PFS)
From day of randomization to disease progression or death, whichever came first, assessed up to 60 months
Study Arms (2)
Masitinib & gemcitabine
EXPERIMENTALParticipants 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.
Placebo & gemcitabine
PLACEBO COMPARATORParticipants 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.
Interventions
Masitinib at 9 mg/kg/day given orally twice daily
Gemcitabine at 1000 mg/m2 by intravenous infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AB Sciencelead
Study Sites (68)
Eastern Connecticut Hematology and Oncology (ECHO)
Norwich, Connecticut, 06360, United States
MD Anderson
Orlando, Florida, 32806, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Medical & Surgical Specialists
Galesburg, Illinois, 61401, United States
Berkshire Hematology Oncology
Pittsfield, Massachusetts, 01201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Metro MN CCOP
Saint Louis Park, Minnesota, 55416, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Teaching Hospital Brno-Bohunice
Brno, 625 00, Czechia
Hospital Chomutov
Chomutov, 430 12, Czechia
Oncology Surgery
Kutná Hora, 284 30, Czechia
Department of Oncology Teaching Hospital Olomouc
Olomouc, 775 20, Czechia
Teaching Hospital Královské
Prague, 100 34, Czechia
Teaching Hospital Na Bulovce
Prague, 180 81, Czechia
Hospital na Homolce
Prague, 5 150 30, Czechia
CHU Amiens
Amiens, 80000, France
Hôpital Privé d'Antony
Antony, 92160, France
Institut Sainte-Catherine
Avignon, 84000, France
Hôpital Jean Minjoz
Besançon, France
Hôpital Saint-André
Bordeaux, France
CHU de la Cavale Blanche
Brest, 29600, France
CHU de Caen
Caen, 14000, France
CHU Hôtel Dieu
Clermont-Ferrand, 63000, France
Groupement Hospitalier Universitaire Nord - Beaujon
Clichy, 92, France
CHU Henri Mondor
Créteil, 94000, France
CHU Henri Mondor
Créteil, France
Hôpital Victor Jousselin
Dreux, France
Centre Gastro-Loire
Gien, 45500, France
Institut Daniel Hollard
Grenoble, 38000, France
CHD Les Oudairies
La Roche-sur-Yon, 85925, France
Hôpital André Mignot
Le Chesnay, 78150, France
Hôpital Robert Boulin
Libourne, 33500, France
Hôpital Claude Huriez
Lille, 59000, France
Centre Hospitalier de Longjumeau
Longjumeau, 91164, France
Hôpital Privé Jean Mermoz
Lyon, 69000, France
Hôpital Edouard Herriot
Lyon, 69003, France
Centre Léon Bérard
Lyon, France
Assistance Publique des Hôpitaux de Marseille
Marseille, 13000, France
Hôpital Saint Joseph
Marseille, 13000, France
Centre Hospitalier Belfort - Montbéliard
Montbéliard, 25200, France
CHU Hôtel Dieu
Nantes, 44000, France
Centre Catherine de Sienne
Nantes, 44200, France
Hôpital de la Source
Orléans, 45000, France
Groupe Hospitalier Diaconesse Croix Saint Simon
Paris, 75000, France
Hôpital Tenon
Paris, 75020, France
Hôpital Hôtel Dieu
Paris, France
Hôpital Saint-Joseph
Paris, France
Hôpital Haut-Lévêque
Pessac, 33600, France
Polyclinique Francheville
Périgueux, 24000, France
Hôpital Hautepierre
Strasbourg, 67200, France
CHU Brabois
Vandœuvre-lès-Nancy, 54500, France
Hôpital Paul Brousse
Villejuif, 94800, 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, 310013, Romania
County Hospital
Baia Mare, 430031, Romania
Emergency Clinical Hospital
Constanța, 900591, Romania
Pelica Impex SRL Hospital
Pelica Impex, 410548, Romania
County Hospital
Satu Mare, 440056, Romania
Related Publications (1)
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.
PMID: 25858497RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaël Deplanque, MD
Hôpital Saint Joseph, Paris, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 13, 2008
Study Start
November 25, 2008
Primary Completion
December 23, 2011
Study Completion
August 31, 2012
Last Updated
December 17, 2018
Record last verified: 2018-12