Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01694277|
Recruitment Status : Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumors||Drug: Masitinib Drug: Sunitinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Participants receive masitinib (12 mg/kg/day), given orally twice daily.
Other Name: AB1010
Active Comparator: Sunitinib
Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
Other Name: Sutent
- Overall Survival (OS) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
- Survival rate [ Time Frame: Every 12 weeks until study completion, assessed for a maximum of 60 months ]Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.
- Progression Free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria and/or CHOI criteria.
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): NCT01694277
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Bordeaux, France, 33000|
|Hôpital l'Archet 2- Service de Cancérologie Digestive|
|Nice, France, 06202|
|Istituto per la Ricerca e la Cura del Cancro (IRCC)|
|Candiolo, Italy, 10060|
|Erasmus University Medical Center|
|Rotterdam, Netherlands, 3015 GD|
|Principal Investigator:||Axel Le Cesne, M.D., Ph.D||Institute Gustave Roussy|