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

A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study 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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01506336

Enrollment

Registered

2012-01-10

Start date

2008-10-31

Completion date

2012-04-30

Last updated

2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Intestinal Stromal Tumor

Keywords

GIST, resistant, imatinib, gastro intestinal stromal tumor resistant to imatinib

Brief summary

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.

Interventions

DRUGmasitinib

masitinib 12 mg/kg/day

DRUGsunitinib

sunitinib 50 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
overall progression free survival	up to 36 weeks	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks

Secondary

Measure	Time frame	Description
overall survival	up to 36 weeks	From date of randomization until the date of death from any cause, assessed up to 36 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026