A prospective, multicenter, randomized, open-label, active-controlled, phase III study to compare efficacy and safety of masitinib to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment

Phase 3

Recruiting

• Conditions: Gastro-Intestinal Stroma Tumor; GIST; 10017990

• Registration Number: NL-OMON44826
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST
2. Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after
imatinib discontinuation
3. Measurable tumour lesions with longest diameter >= 20 mm using conventional techniques or >= 10 mm with
spiral CT scan according RECIST criteria
4. C-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-kit negative
5. ECOG < 1
6. Patient with adequate organ function:

Exclusion Criteria

1. Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2
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 with active central nervous system (CNS) metastasis or with history of CNS metastasis
4. Patient presenting with cardiac disorders defined by at least one of the following conditions:· Patient with recent cardiac history (within 6 months) of:
- Acute coronary syndrome
- Acute heart failure (class III or IV of the NYHA classification)
- 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 aetiology within 3 months· Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
5. 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
6. Patient with 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
7. Treatment with any investigational agent within 4 weeks prior baseline
8. Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified