Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00789633
- Lead Sponsor
- AB Science
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo & gemcitabine Placebo 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. Masitinib & gemcitabine 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. Placebo & gemcitabine 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. Masitinib & gemcitabine Masitinib 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From day of randomization to the date of death, assessed up to 60 months 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.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) From day of randomization to disease progression or death, whichever came first, assessed up to 60 months 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.
Survival rate Every 24 weeks, assessed up to 60 months Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.
Trial Locations
- Locations (65)
Hôpital André Mignot
🇫🇷Le Chesnay, France
Emergency Clinical Hospital
🇷🇴Constanta, Romania
Oncology Surgery
🇨🇿Kutná Hora, Czechia
Teaching Hospital Na Bulovce
🇨🇿Prague 8, Czechia
Department of Oncology Teaching Hospital Olomouc
🇨🇿Olomouc, Czechia
Hospital Chomutov
🇨🇿Chomutov, Czechia
Metro MN CCOP
🇺🇸Saint Louis Park, Minnesota, United States
Berkshire Hematology Oncology
🇺🇸Pittsfield, Massachusetts, United States
Hôpital Privé d'Antony
🇫🇷Antony, France
Teaching Hospital Brno-Bohunice
🇨🇿Brno, Czechia
Medical & Surgical Specialists
🇺🇸Galesburg, Illinois, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
Municipal Clinical Hospital
🇷🇴Arad, Romania
Middle East Institute of Health- Bsaleem
🇱🇧Metn, Lebanon
CHU de la Cavale Blanche
🇫🇷Brest, France
CHU Amiens
🇫🇷Amiens, France
County Hospital
🇷🇴Satu Mare, Romania
Hôpital Edouard Herriot
🇫🇷Lyon, France
Hôpital Tenon
🇫🇷Paris, France
Centre Gastro-Loire
🇫🇷Gien, France
Hotel Dieu de France
🇱🇧Beirut, Lebanon
Centre Catherine de Sienne
🇫🇷Nantes, France
Saint Georges Hospital UMC
🇱🇧Beirut, Lebanon
Groupe Hospitalier Diaconesse Croix Saint Simon
🇫🇷Paris, France
Pelica Impex SRL Hospital
🇷🇴Pelica Impex, Romania
CHU Brabois
🇫🇷Vandoeuvre lès Nancy, France
Saint Joseph Hospital Baouchrieh
🇱🇧Metn, Lebanon
Hammoud Hospital University Medical Center
🇱🇧Saida, Lebanon
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
CHU de Caen
🇫🇷Caen, France
CHU Hôtel Dieu
🇫🇷Nantes, France
Hôpital Victor Jousselin
🇫🇷Dreux, France
Institut Sainte-Catherine
🇫🇷Avignon, France
Institut Daniel Hollard
🇫🇷Grenoble, France
CHD Les Oudairies
🇫🇷La Roche sur Yon, France
Centre Hospitalier de Longjumeau
🇫🇷Longjumeau, France
Hôpital de la Source
🇫🇷Orléans, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
Centre Léon Bérard
🇫🇷Lyon, France
Hôpital Hôtel Dieu
🇫🇷Paris, France
Polyclinique Francheville
🇫🇷Perigueux, France
Hôpital Haut-Lévêque
🇫🇷Pessac, France
Hôpital Hautepierre
🇫🇷Strasbourg, France
Hôpital Paul Brousse
🇫🇷Villejuif, France
Hôpital Saint-André
🇫🇷Bordeaux, France
Hôpital Jean Minjoz
🇫🇷Besançon, France
Hôpital Robert Boulin
🇫🇷Libourne, France
MD Anderson
🇺🇸Orlando, Florida, United States
Eastern Connecticut Hematology and Oncology (ECHO)
🇺🇸Norwich, Connecticut, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Saint Luke's Cancer Institute
🇺🇸Kansas City, Missouri, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
Hospital na Homolce
🇨🇿Prague, Czechia
CHU Henri Mondor
🇫🇷Créteil, France
Teaching Hospital Královské
🇨🇿Prague 10, Czechia
Groupement Hospitalier Universitaire Nord - Beaujon
🇫🇷Clichy, France
Hôpital Claude Huriez
🇫🇷Lille, France
Assistance Publique des Hôpitaux de Marseille
🇫🇷Marseille, France
Hôpital Saint Joseph
🇫🇷Marseille, France
Centre Hospitalier Belfort - Montbéliard
🇫🇷Montbeliard, France
Hôpital Saint-Joseph
🇫🇷Paris, France
Rafik Hariri University Hospital
🇱🇧Beirut, Lebanon
Makassed General Hospital Tarik Jadide
🇱🇧Beirut, Lebanon
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States