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Sponsored by: |
AB Science |
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Information provided by: | AB Science |
ClinicalTrials.gov Identifier: | NCT00789633 |
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 Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 320 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
masitinib in combination with gemcitabine
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Drug: masitinib
9 mg/kg/day
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2: Placebo Comparator
placebo in combination with gemcitabine
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Drug: placebo
matching placebo
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contact: Gaël Deplanque, MD | +33 1 44 12 30 78 | gdeplanque@hpsj.fr |
United States, Connecticut | |
Eastern Connecticut Hematology and Oncology (ECHO) | Recruiting |
Norwich, Connecticut, United States | |
United States, Massachusetts | |
Berkshire Hematology Oncology | Recruiting |
Pittsfield, Massachusetts, United States | |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States | |
France | |
Hôpital Saint-Joseph | Recruiting |
Paris, France | |
Contact: , MD | |
Hôpital Jean Minjoz | Recruiting |
Besançon, France | |
Hôpital Saint-André | Recruiting |
Bordeaux, France | |
Hôpital Victor Jousselin | Recruiting |
Dreux, France | |
Centre Léon Bérard | Recruiting |
Lyon, France | |
Hôpital Edouard Herriot | Recruiting |
Lyon, France | |
Hôpital Haut-Lévêque | Recruiting |
Pessac, France | |
Hôpital de la Source | Recruiting |
Orléans, France | |
CHU Henri Mondor | Recruiting |
Créteil, France | |
Hôpital Paul Brousse | Recruiting |
Villejuif, France | |
Hôpital Hôtel Dieu | Recruiting |
Paris, France | |
Centre Hospitalier de Longjumeau | Recruiting |
Longjumeau, France | |
CHU de la Cavale Blanche | Recruiting |
Brest, France | |
CHU Hôtel Dieu | Recruiting |
Clermont-Ferrand, France | |
CHD Les Oudairies | Recruiting |
La Roche sur Yon, France | |
Hôpital Claude Huriez | Recruiting |
Lille, France | |
CHU Hôtel Dieu | Recruiting |
Nantes, France | |
Hôpital André Mignot | Recruiting |
Versailles, France | |
Institut Sainte-Catherine | Recruiting |
Avignon, France | |
Hôpital Tenon | Recruiting |
Paris, France |
Responsible Party: | AB Science ( Alain Moussy, CEO ) |
Study ID Numbers: | AB07012 |
Study First Received: | November 12, 2008 |
Last Updated: | November 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00789633 |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency |
Pancreatic cancer Advanced pancreatic cancer Metastatic pancreatic cancer Gemcitabine Chemo-naive |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |