Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

AB Science

Status and phase: Completed; Phase 2

Conditions: Gastro Intestinal Stromal Tumor

Treatments: Drug: masitinib; Drug: sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01506336

AB07001

Details and patient eligibility

About

The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histological proven, metastatic, or locally advanced and non-operable GIST
2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
4. Patients resistant to imatinib at dose of 400 mg/day

Exclusion criteria

1. Patient treated for a cancer other than GIST cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

masitinib

Experimental group

Description:

masitinib 12 mg/kg/day

Treatment:

Drug: masitinib

sunitinib

Active Comparator group

Description:

sunitinib 50 mg/day

Treatment:

Drug: sunitinib