Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00998751

Enrollment

Registered

2009-10-20

Start date

2005-06-30

Completion date

2013-06-30

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 Tumours

Keywords

cKIT inhibitor, GIST

Brief summary

The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.

Interventions

DRUGoral masitinib

7.5 mg/kg/day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or Female patients, age \>18 * Life expectancy \> 6 months * Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST. * Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy * C-Kit (CD117) positive tumors detected immuno-histochemically * Measurable tumor lesions with longest diameter \>20 mm using conventional techniques or \>10 mm with spiral CT scan

Exclusion criteria

* Documented allergy to the similar drug of AB1010 * Inadequate organ function * Patients with a history of any other malignancy

Design outcomes

Primary

Measure	Time frame
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)	2 months

Secondary

Measure	Time frame
Progression Free Survival	until disease progression

Countries

France

Outcome results

None listed

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