A Phase 3 Study to Compare Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Placebo in Combination With Gemcitabine, in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by AB Science.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT00789633
First received: November 12, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: masitinib (AB1010)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AB Science:

Primary Outcome Measures:
  • Overall survival [ Time Frame: until death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival rate, Objective Response Rate, Control Disease Rate, Best Response, Serum level of CA19-9. Progression Free Survival, Time to Progression, Time to Response, Quality of Life questionnaires, Pain and analgesics consumption. [ Time Frame: until death ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
masitinib (AB1010) in combination with gemcitabine
Drug: masitinib (AB1010)
9 mg/kg/day
Other Name: AB1010
Placebo Comparator: 2
placebo in combination with gemcitabine
Drug: placebo
matching placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789633

  Hide Study Locations
Locations
United States, Connecticut
Eastern Connecticut Hematology and Oncology (ECHO)
Norwich, Connecticut, United States, 06360
United States, Florida
MD Anderson
Orlando, Florida, United States, 32806
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Medical & Surgical Specialists
Galesburg, Illinois, United States, 61401
United States, Massachusetts
Berkshire Hematology Oncology
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Metro MN CCOP
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
United States, New Jersey
The Valley Hospital
Paramus, New Jersey, United States, 07652
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Czech Republic
Teaching Hospital Brno-Bohunice
Brno, Czech Republic, 625 00
Hospital Chomutov
Chomutov, Czech Republic, 430 12
Oncology Surgery
Kutná Hora, Czech Republic, 284 30
Department of Oncology Teaching Hospital Olomouc
Olomouc, Czech Republic, 775 20
Hospital na Homolce
Prague, Czech Republic, 5 150 30
Teaching Hospital Královské
Prague 10, Czech Republic, 100 34
Teaching Hospital Na Bulovce
Prague 8, Czech Republic, 180 81
France
CHU Amiens
Amiens, France, 80000
Hôpital Privé d'Antony
Antony, France, 92160
Institut Sainte-Catherine
Avignon, France, 84000
Hôpital Jean Minjoz
Besançon, France
Hôpital Saint-André
Bordeaux, France
CHU de la Cavale Blanche
Brest, France, 29600
CHU de Caen
Caen, France, 14000
CHU Hôtel Dieu
Clermont-Ferrand, France, 63000
Groupement Hospitalier Universitaire Nord - Beaujon
Clichy, France, 92
CHU Henri Mondor
Créteil, France, 94000
CHU Henri Mondor
Créteil, France
Hôpital Victor Jousselin
Dreux, France
Centre Gastro-Loire
Gien, France, 45500
Institut Daniel Hollard
Grenoble, France, 38000
CHD Les Oudairies
La Roche sur Yon, France, 85925
Hôpital André Mignot
Le Chesnay, France, 78150
Hôpital Robert Boulin
Libourne, France, 33500
Hôpital Claude Huriez
Lille, France, 59000
Centre Hospitalier de Longjumeau
Longjumeau, France, 91164
Hôpital Edouard Herriot
Lyon, France, 69003
Hôpital Privé Jean Mermoz
Lyon, France, 69000
Centre Léon Bérard
Lyon, France
Hôpital Saint Joseph
Marseille, France, 13000
Assistance Publique des Hôpitaux de Marseille
Marseille, France, 13000
Centre Hospitalier Belfort - Montbéliard
Montbeliard, France, 25200
Centre Catherine de Sienne
Nantes, France, 44200
CHU Hôtel Dieu
Nantes, France, 44000
Hôpital de la Source
Orléans, France, 45000
Hôpital Hôtel Dieu
Paris, France
Groupe Hospitalier Diaconesse Croix Saint Simon
Paris, France, 75000
Hôpital Tenon
Paris, France, 75020
Hôpital Saint-Joseph
Paris, France
Polyclinique Francheville
Perigueux, France, 24000
Hôpital Haut-Lévêque
Pessac, France, 33600
Hôpital Hautepierre
Strasbourg, France, 67200
CHU Brabois
Vandoeuvre lès Nancy, France, 54500
Hôpital Paul Brousse
Villejuif, France, 94800
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
Saint Joseph Hospital Baouchrieh
Metn, Lebanon
Middle East Institute of Health- Bsaleem
Metn, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Romania
Municipal Clinical Hospital
Arad, Romania, 310013
County Hospital
Baia-Mare, Romania, 430031
Emergency Clinical Hospital
Constanta, Romania, 900591
Pelica Impex SRL Hospital
Pelica Impex, Romania, 410548
County Hospital
Satu Mare, Romania, 440056
Sponsors and Collaborators
AB Science
Investigators
Principal Investigator: Gaël Deplanque, MD Hôpital Saint Joseph, Paris, France
  More Information

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00789633     History of Changes
Other Study ID Numbers: AB07012
Study First Received: November 12, 2008
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AB Science:
Pancreatic cancer
Advanced pancreatic cancer
Metastatic pancreatic cancer
Gemcitabine
Chemo-naive

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014