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| Sponsor: | AB Science |
|---|---|
| Information provided by: | AB Science |
| ClinicalTrials.gov Identifier: | NCT00812240 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
masitinib 7.5 mg/kg/day, per os
|
Drug: masitinib (AB1010)
masitinib (AB1010) 7.5 mg/kg/day, per os
|
|
2: Active Comparator
imatinib 400 mg or 600 mg per day, per os
|
Drug: imatinib
imatinib 400 mg or 600 mg per day, per os
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Antoine Adenis, M.D. | +33 (0)3 20 29 59 59 | a-adenis@o-lambret.fr |
Hide Study Locations| United States, Florida | |
| MD Anderson Cancer Center | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| The Emory Clinic | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| 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 | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact 866-627-7616 osu@emergingmed.com | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | Recruiting |
| Greenville, South Carolina, United States, 290605 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| France | |
| Centre Hospitalier d'Abbeville | Recruiting |
| Abbeville, France, 80142 | |
| Institut Sainte Catherine | Recruiting |
| Avignon, France, 84000 | |
| Hôpital Jean Minjoz | Recruiting |
| Besançon, France, 25000 | |
| Centre Hospitalier Robert Boulin | Recruiting |
| Libourne, France, 33500 | |
| Hôpital Morvan | Recruiting |
| Brest, France, 29200 | |
| Hôpitalo Henri Mondor | Recruiting |
| Créteil, France, 94000 | |
| Centre Georges François Leclerc | Recruiting |
| Dijon, France, 21000 | |
| Centre Hospitalier Victor Jousselin | Recruiting |
| Dreux, France, 28100 | |
| Clinique Pasteur | Recruiting |
| Evreux, France, 27000 | |
| Centre Hospitalier de Gap | Recruiting |
| Gap, France, 05000 | |
| CHD de Vendée | Recruiting |
| La Roche sur Yon, France, 85925 | |
| Centre Hsopitalier de La Rochelle | Recruiting |
| La Rochelle, France, 17000 | |
| Institut Bergonié | Recruiting |
| Bordeaux, France, 33000 | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59000 | |
| Centre Léon Bérard | Recruiting |
| Lyon, France, 69000 | |
| Institut Paoli Calmette | Recruiting |
| Marseille, France, 13200 | |
| Centre Val d'Aurèle | Recruiting |
| Montpellier, France, 34000 | |
| Centre René Gauducheau | Recruiting |
| Nantes, France, 44800 | |
| Hôpital de la Source | Recruiting |
| Orléans, France, 45000 | |
| Hôpital Robert Debré | Recruiting |
| Reims, France, 51000 | |
| Hôpital Bichat Claude Bernard | Recruiting |
| Paris, France, 75018 | |
| Groupe Hospitalier Diaconesse Croix Saint Simon | Recruiting |
| Paris, France, 75012 | |
| Hôpital Tenon | Recruiting |
| Paris, France, 75020 | |
| Hôpital Européen Georges Pompidou | Recruiting |
| Paris, France, 75015 | |
| Hôpital Charles Nicolle | Recruiting |
| Rouen, France, 76000 | |
| Centre René Huguenin | Recruiting |
| Saint-Cloud, France, 92210 | |
| Clinique Armoricaine de Radiologie | Recruiting |
| Saint Brieuc, France, 22000 | |
| Lebanon | |
| Hôpital Saint-Georges | Recruiting |
| Beirut, Lebanon | |
| Hotel Dieu de France | Recruiting |
| Beirut, Lebanon | |
| Hammoud Hospital University Medical Center | Recruiting |
| Saida, Lebanon | |
| Rafik Hariri University Hospital | Recruiting |
| Beirut, Lebanon | |
| Hôpital Saint-Joseph | Recruiting |
| Metn, Lebanon | |
| Middle East Institute of Health- Bsaleem | Recruiting |
| Metn, Lebanon | |
| Makassed General Hospital Tarik Jadide | Recruiting |
| Beirut, Lebanon | |
| Principal Investigator: | Atoine Adenis, MD | Centre Oscar Lambret, Lille, France |
More Information
| Responsible Party: | AB Science ( Alain Moussy, CEO ) |
| Study ID Numbers: | AB04030 |
| Study First Received: | December 19, 2008 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00812240 History of Changes |
| 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 |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Imatinib Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |