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Sponsored by: |
AB Science |
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Information provided by: | AB Science |
ClinicalTrials.gov Identifier: | NCT00812240 |
The objective of the study is to compare the efficacy and safety of masitinib to imatinib in patients with gastro-intestinal stromal tumour (GIST) in first line medical treatment.
Condition | Intervention | Phase |
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Gastrointestinal Stromal Tumors |
Drug: masitinib (AB1010) Drug: imatinib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multicenter, Randomized, Open-Label, Active-Controlled, 2-Parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment |
Estimated Enrollment: | 222 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
masitinib 7.5 mg/kg/day, per os
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Drug: masitinib (AB1010)
masitinib (AB1010) 7.5 mg/kg/day, per os
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2: Active Comparator
imatinib 400 mg or 600 mg per day, per os
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Drug: imatinib
imatinib 400 mg or 600 mg per day, per os
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GISTs are uncommon visceral sarcomas that arise predominantly in the gastro-intestinal tract. Most GIST cells are positive for c-kit (CD117), a cell surface antigen corresponding to the Stem Cell Factor (SCF) receptor. The receptor has an intracellular tyrosine kinase (TK) joined by a juxtamembrane domain. It is hypothesized that all malignant GIST cells harbor a mutation of c-kit, resulting in the activation of c-kit and cell division and tumour growth. Drugs that can selectively inhibit TKs are likely to be of benefit in GISTs. Masitinib (AB1010) is a TK inhibitor, selectively and effectively inhibiting c-kit. Imatinib is also a TK inhibitor indicated in the treatment of GIST. It might be associated with side effects and patients might develop a resistance to treatment over time. Based on pre-clinical and clinical studies, masitinib (AB1010) can be considered as a good candidate in the first line treatment of patients with GIST.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Antoine Adenis, M.D. | +33 (0)3 20 29 59 59 | a-adenis@o-lambret.fr |
United States, Florida | |
MD Anderson Cancer Center | Recruiting |
Orlando, Florida, United States, 32806 | |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
Beth Israel Medical Center | Recruiting |
New York, New York, United States, 10003 | |
France | |
Centre Oscar Lambret | Recruiting |
Lille, France | |
Centre Léon Bérard | Recruiting |
Lyon, France | |
Centre Georges François Leclerc | Recruiting |
Dijon, France | |
Hôpital Charles Nicolle | Recruiting |
Rouen, France | |
Centre Hospitalier Victor Jousselin | Recruiting |
Dreux, France | |
Centre René Huguenin | Recruiting |
Saint-Cloud, France | |
Centre René Gauducheau | Recruiting |
Nantes, France | |
Hôpital Jean Minjoz | Recruiting |
Besançon, France | |
Institut Paoli Calmette | Recruiting |
Marseille, France | |
Centre Val d'Aurèle | Recruiting |
Montpellier, France | |
Hôpital de la Source | Recruiting |
Orléans, France | |
Hôpital Européen Georges Pompidou | Recruiting |
Paris, France | |
Institut Bergonié | Recruiting |
Bordeaux, France | |
Hôpital Robert Debré | Recruiting |
Reims, France | |
Lebanon | |
Recruiting | |
Beirut, Lebanon | |
Hôpital Saint-Georges | Recruiting |
Beirut, Lebanon | |
Hôpital Saint-Joseph | Recruiting |
Dora, Lebanon | |
Middle East Institute of Health | Recruiting |
Bsalim, Lebanon | |
Hamoud Hospital | Recruiting |
Saida, Lebanon | |
American University Hospital | Recruiting |
Beirut, Lebanon |
Responsible Party: | AB Science ( Alain Moussy, CEO ) |
Study ID Numbers: | AB04030 |
Study First Received: | December 19, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00812240 |
Health Authority: | United States: Food and Drug Administration; France: Direction Générale de la Santé; Lebanon: Ministry of Public Health |
Gastro-Intestinal Stromal Tumour GIST non resectable recurrent post-surgery |
first line of treatment metastatic locally advanced |
Imatinib Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |