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Trial record 64 of 300 for:    Gastrointestinal Stromal Tumors

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

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ClinicalTrials.gov Identifier: NCT00998751
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

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.

Condition or disease Intervention/treatment Phase
Gastro-intestinal Stromal Tumours Drug: oral masitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
Study Start Date : June 2005
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013


Arm Intervention/treatment
Experimental: masitinib (AB1010)
oral masitinib 7.5 mg/kg/day
Drug: oral masitinib
7.5 mg/kg/day
Other Name: AB1010




Primary Outcome Measures :
  1. Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: until disease progression ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998751


Locations
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France
Lecesne
Villejuif, France
Sponsors and Collaborators
AB Science
Additional Information:
Publications of Results:
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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00998751    
Other Study ID Numbers: AB04016
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Keywords provided by AB Science:
cKIT inhibitor
GIST
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases