Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Advanced pancreatic cancer, Metastatic pancreatic cancer, Gemcitabine, Chemo-naive
Eligibility Criteria
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
Sites / Locations
- Eastern Connecticut Hematology and Oncology (ECHO)
- MD Anderson
- The Emory Clinic
- Decatur Memorial Hospital
- Medical & Surgical Specialists
- Berkshire Hematology Oncology
- Henry Ford Health System
- Metro MN CCOP
- Saint Luke's Cancer Institute
- The Valley Hospital
- Southeastern Medical Oncology Center
- Oregon Health & Science University
- Teaching Hospital Brno-Bohunice
- Hospital Chomutov
- Oncology Surgery
- Department of Oncology Teaching Hospital Olomouc
- Teaching Hospital Královské
- Teaching Hospital Na Bulovce
- Hospital na Homolce
- CHU Amiens
- Hôpital Privé d'Antony
- Institut Sainte-Catherine
- Hôpital Jean Minjoz
- Hôpital Saint-André
- CHU de la Cavale Blanche
- CHU de Caen
- CHU Hôtel Dieu
- Groupement Hospitalier Universitaire Nord - Beaujon
- CHU Henri Mondor
- CHU Henri Mondor
- Hôpital Victor Jousselin
- Centre Gastro-Loire
- Institut Daniel Hollard
- CHD Les Oudairies
- Hôpital André Mignot
- Hôpital Robert Boulin
- Hôpital Claude Huriez
- Centre Hospitalier de Longjumeau
- Hôpital Privé Jean Mermoz
- Hôpital Edouard Herriot
- Centre Léon Bérard
- Assistance Publique des Hôpitaux de Marseille
- Hôpital Saint Joseph
- Centre Hospitalier Belfort - Montbéliard
- CHU Hôtel Dieu
- Centre Catherine de Sienne
- Hôpital de la Source
- Groupe Hospitalier Diaconesse Croix Saint Simon
- Hôpital Tenon
- Hôpital Hôtel Dieu
- Hôpital Saint-Joseph
- Polyclinique Francheville
- Hôpital Haut-Lévêque
- Hôpital Hautepierre
- CHU Brabois
- Hôpital Paul Brousse
- Hotel Dieu de France
- Makassed General Hospital Tarik Jadide
- Rafik Hariri University Hospital
- Saint Georges Hospital UMC
- Middle East Institute of Health- Bsaleem
- Saint Joseph Hospital Baouchrieh
- Hammoud Hospital University Medical Center
- Municipal Clinical Hospital
- County Hospital
- Emergency Clinical Hospital
- Pelica Impex SRL Hospital
- County Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Masitinib & gemcitabine
Placebo & 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.
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.