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

Gastro-intestinal Stromal Tumours Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998751
• Other study ID #: AB04016
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Est. completion date: June 2013

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro-intestinal Stromal Tumours
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• oral masitinib
7.5 mg/kg/day

Locations

Country	Name	City	State
France	Lecesne	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Country where clinical trial is conducted

France, 

References & Publications (1)

Le Cesne A, Blay JY, Bui BN, Bouché 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-naïve patients with locally advanced or metastatic gastro-intest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)		2 months
Secondary	Progression Free Survival		until disease progression

External Links

•   Publication of results