Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients

Phase 2

Completed

Brief Summary: The objective is to evaluate the efficacy and safety of masitinib in combination with gemcitabine in refractory ovarian cancer patients.

Detailed Description: Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine as compared with single agent gemcitabine in advanced or metastatic epithelial ovarian cancer patients who are refractory to platinum treatment. This is an open-label, randomized, active-controlled, phase 2/3 study. The study's primary efficacy measure will be overall survival. Masitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal. The study design is a two-stage adaptive design, meaning that it includes a prospectively planned opportunity for modification of one or more specified aspects of the study (for example patient enrollment).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo & gemcitabine	Placebo	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.
Masitinib & gemcitabine	Masitinib	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.
Masitinib & gemcitabine	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.
Placebo & gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Progression Free Survival (PFS)	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.

Locations (6): Centre hospitalo-universitaire de Beni Messous
🇩🇿
Algiers, Algeria
City Oncology Clinic
🇷🇺
St.-Petersburg, Russian Federation
Institut Sainte Catherine
🇫🇷
Avignon, France
Lviv State Oncological Regional Treatment and Diagnostic Center
🇺🇦
Lviv, Ukraine
Complejo Hospitalario Universitario de Santiago
🇪🇸
Santiago, Spain
University Hospital Coventry
🇬🇧
Coventry, United Kingdom