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Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

NCT ID: NCT01694277

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

Conditions

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Gastrointestinal Stromal Tumors

Keywords

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Gastrointestinal Stromal Tumour GIST non-resectable metastatic second line treatment resistance to imatinib tyrosine kinase inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Masitinib

Participants receive masitinib (12 mg/kg/day), given orally twice daily.

Group Type EXPERIMENTAL

Masitinib

Intervention Type DRUG

12 mg/kg/day

Sunitinib

Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally

Group Type ACTIVE_COMPARATOR

Sunitinib

Intervention Type DRUG

50 mg/day

Interventions

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Masitinib

12 mg/kg/day

Intervention Type DRUG

Sunitinib

50 mg/day

Intervention Type DRUG

Other Intervention Names

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AB1010 Sutent

Eligibility Criteria

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Inclusion Criteria

* Patient with histological proven metastatic GIST or non-operable locally advanced GIST
* Patient with c-Kit (CD117) positive tumor detected immuno-histochemically
* Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment.

Exclusion Criteria

* 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
* Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
* Pregnant, or nursing female patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel Le Cesne, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Institute Gustave Roussy

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

Hôpital l'Archet 2- Service de Cancérologie Digestive

Nice, , France

Site Status

Istituto per la Ricerca e la Cura del Cancro (IRCC)

Candiolo, , Italy

Site Status

Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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United States France Italy Netherlands

Other Identifiers

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AB11002

Identifier Type: -

Identifier Source: org_study_id