A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment
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ClinicalTrials.gov Identifier: NCT00812240 |
Recruitment Status
: Unknown
Verified September 2012 by AB Science.
Recruitment status was: Recruiting
First Posted
: December 22, 2008
Last Update Posted
: September 26, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Stromal Tumors | Drug: masitinib (AB1010) Drug: imatinib | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 222 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumour in First Line Medical Treatment |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
masitinib 7.5 mg/kg/day, per os
|
Drug: masitinib (AB1010)
masitinib (AB1010) 7.5 mg/kg/day, per os
Other Name: AB1010
|
Active Comparator: 2
imatinib 400 mg or 600 mg per day, per os
|
Drug: imatinib
imatinib 400 mg or 600 mg per day, per os
|
- Progression Free Survival [ Time Frame: 24 months ]
- Overall survival [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST
- Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
- C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative
- Man or woman, age >18 years
- Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake
- Patient able and willing to comply with study procedures as per protocol
- Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
Exclusion Criteria:
- Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2
- 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
- Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline) Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
- Treatment with any investigational agent within 4 weeks prior baseline
- Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline

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): NCT00812240
Contact: Antoine Adenis, M.D. | +33 (0)3 20 29 59 59 | a-adenis@o-lambret.fr |

Principal Investigator: | Antoine Adenis, MD | Centre Oscar Lambret, Lille, France |
Responsible Party: | AB Science |
ClinicalTrials.gov Identifier: | NCT00812240 History of Changes |
Other Study ID Numbers: |
AB04030 |
First Posted: | December 22, 2008 Key Record Dates |
Last Update Posted: | September 26, 2012 |
Last Verified: | September 2012 |
Keywords provided by AB Science:
Gastro-Intestinal Stromal Tumour GIST non resectable recurrent post-surgery |
first line of treatment metastatic locally advanced |
Additional relevant MeSH terms:
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 Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |