Clinical trial NCT00789633: Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Advanced pancreatic cancer
Metastatic pancreatic cancer
Gemcitabine
Chemo-naive
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Main Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
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.

Main Exclusion Criteria:

1. 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
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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From day of randomization to the date of death, assessed up to 60 months
Secondary outcomes:
measure: Survival rate
timeFrame: Every 24 weeks, assessed up to 60 months
measure: Progression Free Survival (PFS)
timeFrame: From day of randomization to disease progression or death, whichever came first, assessed up to 60 months
Other outcomes:
Locations:
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology (ECHO)
state: Connecticut
city: Orlando
country: United States
facility: MD Anderson
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Galesburg
country: United States
facility: Medical & Surgical Specialists
state: Illinois
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro MN CCOP
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Missouri
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Brno
country: Czechia
facility: Teaching Hospital Brno-Bohunice
city: Chomutov
country: Czechia
facility: Hospital Chomutov
city: Kutná Hora
country: Czechia
facility: Oncology Surgery
city: Olomouc
country: Czechia
facility: Department of Oncology Teaching Hospital Olomouc
city: Prague 10
country: Czechia
facility: Teaching Hospital Královské
city: Prague 8
country: Czechia
facility: Teaching Hospital Na Bulovce
city: Prague
country: Czechia
facility: Hospital na Homolce
city: Amiens
country: France
facility: CHU Amiens
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Brest
country: France
facility: CHU de la Cavale Blanche
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU Hôtel Dieu
city: Clichy
country: France
facility: Groupement Hospitalier Universitaire Nord - Beaujon
city: Créteil
country: France
facility: CHU Henri Mondor
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dreux
country: France
facility: Hôpital Victor Jousselin
city: Gien
country: France
facility: Centre Gastro-Loire
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: La Roche sur Yon
country: France
facility: CHD Les Oudairies
city: Le Chesnay
country: France
facility: Hôpital André Mignot
city: Libourne
country: France
facility: Hôpital Robert Boulin
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Longjumeau
country: France
facility: Centre Hospitalier de Longjumeau
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Assistance Publique des Hôpitaux de Marseille
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montbeliard
country: France
facility: Centre Hospitalier Belfort - Montbéliard
city: Nantes
country: France
facility: CHU Hôtel Dieu
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Orléans
country: France
facility: Hôpital de la Source
city: Paris
country: France
facility: Groupe Hospitalier Diaconesse Croix Saint Simon
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Hôtel Dieu
city: Paris
country: France
facility: Hôpital Saint-Joseph
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Vandoeuvre lès Nancy
country: France
facility: CHU Brabois
city: Villejuif
country: France
facility: Hôpital Paul Brousse
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
city: Beirut
country: Lebanon
facility: Makassed General Hospital Tarik Jadide
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Beirut
country: Lebanon
facility: Saint Georges Hospital UMC
city: Metn
country: Lebanon
facility: Middle East Institute of Health- Bsaleem
city: Metn
country: Lebanon
facility: Saint Joseph Hospital Baouchrieh
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Arad
country: Romania
facility: Municipal Clinical Hospital
city: Baia-Mare
country: Romania
facility: County Hospital
city: Constanta
country: Romania
facility: Emergency Clinical Hospital
city: Pelica Impex
country: Romania
facility: Pelica Impex SRL Hospital
city: Satu Mare
country: Romania
facility: County Hospital
Study officials:
affiliation: Hôpital Saint Joseph, Paris, France
name: Gaël Deplanque, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.