stromal gastrointestinal cancer MedDRA version: 17.1 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864
Conditions
Sponsors
AB Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with histologic diagnosis of localized, primary GIST 2. Patient with measurable primary tumor lesion using conventional techniques or spiral CT scan assessed before tumor resection 3. Patient stopped imatinib as adjuvant therapy without progression OR patient not eligible for imatinib as adjuvant therapy 4. Patient with a high risk of recurrence, i.e., patients with primary tumor diameter > 5 cm and mitotic count > 5/50 HPF, or tumor diameter > 10 cm and any mitotic count, or tumor of any size with mitotic count > 10/50 HPF, or tumors that have ruptured into the peritoneal cavity 5. Patient without peritoneal or distant metastasis 6. Patient with c-kit (CD117) positive primary tumor detected immuno-histochemically 7. Patient after gross tumor resection (regardless of microscopic margins) within the past 14-70 days after surgery (R0 resection: negative microscopic margins or R1 resection: positive microscopic margins) 8. Patient free of tumor by post-operative imaging that included a baseline chest x-ray (or chest CT) and a post-operative abdomen and pelvis CT scan with intravenous and oral contrast or MRI with intravenous contrast within 28 days before the randomization 9. Patient with ECOG ? 2 10. Patient with adequate organ functions: 1. Patient avec confirmation histologique d?un GIST primaire localisée 2. Patient ayant des lésions tumorales primaires utilisant les techniques de mesure conventionnelles ou en utilisant un scanner spiralé avant résection de la tumeur 3. Patient ayant arête l?imatinib en adjuvant thérapie sans progression OU patient non éligible à l?imatinib en adjuvant thérapie 4. Patient avec un risqué élevé de récidive : patient avec une tumeur primaire d?un diamètre > 5 cm et un indice mitotique > 5/50 HPF, ou une tumeur d?un diamètre > 10 cm quelque soit l?indice mitotique, ou quelque soit la taille de la tumeur avec un indice mitotique > 10/50 HPF ou des tumeurs qui sont rompues dans la cavité péritonéale 5. Patient sans métastases péritonéales 6. Patient ayant une tumeur C-kit (CD117) positive détectée de façon immuno-histochimique 7. Patient après résection de la tumeur brut (indépendamment des marges microscopiques) dans les 14-70 derniers jours après la chirurgie (résection R0: marges microscopiques négatives ou résection R1: marges microscopiques positives) 8. Patient sans tumeur vérifiée par imagerie post-opératoire qui comprend une radiographie thoracique (ou scanner) et un scanner post-opératoire de l?abdomen et du bassin et du bassin avec contraste (intraveineux et oral) ou une 'IRM avec contraste intraveineux dans les 28 jours avant la randomisation 9. Patient ayant un ECOG ? 2 10. Patient ayant des fonctions organiques adéquates Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 230
Exclusion criteria
Exclusion criteria: . Patient with metastases of the primary GIST tumor 2. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ 3. Patient progressed under imatinib as adjuvant therapy 4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis 5. Patient presenting with cardiac disorders defined by at least one of the following conditions: ? Patient with recent cardiac history (within 6 months) of: o Acute coronary syndrome o Acute heart failure (class III or IV of the NYHA classification) o Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) ? Patient with cardiac failure class III or IV of the NYHA classification ? Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) ? Syncope without known etiology within 3 months ? Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension 6. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 7. Pregnant, or nursing female patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to compare the efficacy of masitinib at 4.5 mg/kg/day to placebo;Secondary Objective: The objective is to compare the safety of masitinib at 4.5 mg/kg/day to placebo;Primary end point(s): Recurrence Free Survival (RFS) as evaluated by independent review;Timepoint(s) of evaluation of this end point: Recurrence Free Survival (RFS) is defined as the time from the date of randomization to the date of death due to any cause during the study or to the time of development of tumor recurrence, whichever comes first. Recurrence is defined as recurrence of primary tumor or emergence of new tumor assessed by CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Overall Survival (OS) defined as the time from the date of randomization to the date of documented death. ? Time To Recurrence (TTR) as evaluated by independent review and investigator ? Safety profile using the NCI CTC v4.0 classification;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Argentina, Austria, Belgium, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hungary, India, Indonesia, Italy, Morocco, Netherlands, Peru, Philippines, Poland, Russian Federation, Spain, Taiwan, Tunisia, Ukraine, United Kingdom, United States
Contacts
Public ContactCatherine Léger
AB Science
Outcome results
None listed