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

Primary Purpose

Gastro-intestinal Stromal Tumours

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

oral masitinib

About this trial

This is an interventional treatment trial for Gastro-intestinal Stromal Tumours focused on measuring cKIT inhibitor, GIST

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Lecesne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

masitinib (AB1010)

Arm Description

oral masitinib 7.5 mg/kg/day

Outcomes

Primary Outcome Measures

Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)

Secondary Outcome Measures

Progression Free Survival

Full Information

NCT ID

NCT00998751

First Posted

October 19, 2009

Last Updated

December 8, 2018

Sponsor

AB Science

1. Study Identification

Unique Protocol Identification Number

NCT00998751

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AB Science

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastro-intestinal Stromal Tumours

Keywords

cKIT inhibitor, GIST

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

masitinib (AB1010)

Arm Type

Experimental

Arm Description

oral masitinib 7.5 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

oral masitinib

Other Intervention Name(s)

AB1010

Intervention Description

7.5 mg/kg/day

Primary Outcome Measure Information:

Title

Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Progression Free Survival

Time Frame

until disease progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Lecesne

City

Villejuif

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

20211560

Citation

Le Cesne A, Blay JY, Bui BN, Bouche O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.

Results Reference

result

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

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