Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients
|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: NCT02490488|
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : December 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Masitinib Drug: Gemcitabine Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2/3 Study of Masitinib in Combination With Gemcitabine Versus Gemcitabine Alone in Advanced/Metastatic Epithelial Ovarian Cancer Patients in Second Line Being Refractory to First Line Platinum Treatment or in Third Line|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2020|
|Actual Study Completion Date :||December 2020|
Experimental: Masitinib & gemcitabine
Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine 1000 mg/m² administered by 30 minutes infusion once a week during 3 weeks followed by 1 week without infusion.
Other Name: AB1010
Other Name: Gemzar
Placebo Comparator: Placebo & gemcitabine
Participants receive placebo (6 mg/kg/day), given orally twice daily, plus gemcitabine 1000 mg/m² administered by 30 minutes infusion once a week during 3 weeks followed by 1 week without infusion.
Other Name: Gemzar
Other Name: Placebo Oral Tablet
- 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.
- Overall 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 (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 CT scan according to RECIST criteria recommendations.
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): NCT02490488
|Centre hospitalo-universitaire de Beni Messous|
|Algiers, Algeria, 16340|
|Institut Sainte Catherine|
|Avignon, France, 84000|
|City Oncology Clinic|
|St.-Petersburg, Russian Federation, 198255|
|Complejo Hospitalario Universitario de Santiago|
|Santiago, Spain, 15706|
|Lviv State Oncological Regional Treatment and Diagnostic Center|
|Lviv, Ukraine, 79031|
|University Hospital Coventry|
|Coventry, United Kingdom, CV2 2DX|
|Principal Investigator:||Julien Grenier, Dr||AB Science|