Clinical trial NCT02490488: Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ovarian Cancer
Keywords: ovarian cancer
tyrosine kinase inhibitor
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2015-07-03
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Main inclusion criteria:

1. Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer), which is either:

   * First line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy)
   * First line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy);
   * Candidate to third line of treatment (refractory, resistant, or sensitive to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line).
2. Patient with adequate organ function per laboratory tests evaluations

Main exclusion criteria:

1. Patient intolerant to gemcitabine
2. Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2)
3. Pregnant or nursing female patient

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From day of randomization to death, assessed for a maximum of 60 months
Secondary outcomes:
measure: Overall Progression Free Survival (PFS)
timeFrame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Centre hospitalo-universitaire de Beni Messous
city: Avignon
country: France
facility: Institut Sainte Catherine
city: St.-Petersburg
country: Russian Federation
facility: City Oncology Clinic
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Lviv
country: Ukraine
facility: Lviv State Oncological Regional Treatment and Diagnostic Center
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
Study officials:
affiliation: AB Science
name: Julien Grenier, Dr
role: PRINCIPAL_INVESTIGATOR
References: