Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789633
• Other study ID #: AB07012
• Status: Completed
• Phase: Phase 3
• Start date: November 25, 2008
• Est. completion date: August 31, 2012

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: August 31, 2012
• Est. primary completion date: December 23, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Czechia	Teaching Hospital Brno-Bohunice	Brno
Czechia	Hospital Chomutov	Chomutov
Czechia	Oncology Surgery	Kutná Hora
Czechia	Department of Oncology Teaching Hospital Olomouc	Olomouc
Czechia	Hospital na Homolce	Prague
Czechia	Teaching Hospital Královské	Prague 10
Czechia	Teaching Hospital Na Bulovce	Prague 8
France	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	Centre Léon Bérard	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Privé Jean Mermoz	Lyon
France	Assistance Publique des Hôpitaux de Marseille	Marseille
France	Hôpital Saint Joseph	Marseille
France	Centre Hospitalier Belfort - Montbéliard	Montbeliard
France	Centre Catherine de Sienne	Nantes
France	CHU Hôtel Dieu	Nantes
France	Hôpital de la Source	Orléans
France	Groupe Hospitalier Diaconesse Croix Saint Simon	Paris
France	Hôpital Hôtel Dieu	Paris
France	Hôpital Saint-Joseph	Paris
France	Hôpital Tenon	Paris
France	Polyclinique Francheville	Perigueux
France	Hôpital Haut-Lévêque	Pessac
France	Hôpital Hautepierre	Strasbourg
France	CHU Brabois	Vandoeuvre lès Nancy
France	Hôpital Paul Brousse	Villejuif
Lebanon	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
Romania	Municipal Clinical Hospital	Arad
Romania	County Hospital	Baia-Mare
Romania	Emergency Clinical Hospital	Constanta
Romania	Pelica Impex SRL Hospital	Pelica Impex
Romania	County Hospital	Satu Mare
United States	The Emory Clinic	Atlanta	Georgia
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Medical & Surgical Specialists	Galesburg	Illinois
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Saint Luke's Cancer Institute	Kansas City	Missouri
United States	Eastern Connecticut Hematology and Oncology (ECHO)	Norwich	Connecticut
United States	MD Anderson	Orlando	Florida
United States	The Valley Hospital	Paramus	New Jersey
United States	Berkshire Hematology Oncology	Pittsfield	Massachusetts
United States	Oregon Health & Science University	Portland	Oregon
United States	Metro MN CCOP	Saint Louis Park	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

United States,  Czechia,  France,  Lebanon,  Romania, 

References & Publications (1)

Deplanque G, Demarchi M, Hebbar M, Flynn P, Melichar B, Atkins J, Nowara E, Moyé 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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival rate	Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.	Every 24 weeks, assessed up to 60 months
Secondary	Progression Free Survival (PFS)	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.	From day of randomization to disease progression or death, whichever came first, assessed up to 60 months

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