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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490488
• Other study ID #: AB12008
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2014
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Masitinib

• Gemcitabine

• Placebo

Locations

Country	Name	City	State
Algeria	Centre hospitalo-universitaire de Beni Messous	Algiers
France	Institut Sainte Catherine	Avignon
Russian Federation	City Oncology Clinic	St.-Petersburg
Spain	Complejo Hospitalario Universitario de Santiago	Santiago
Ukraine	Lviv State Oncological Regional Treatment and Diagnostic Center	Lviv
United Kingdom	University Hospital Coventry	Coventry

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

Algeria,  France,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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.	From day of randomization to death, assessed for a maximum of 60 months
Secondary	Overall Progression Free Survival (PFS)	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.	From day of randomization to disease progression or death, assessed for a maximum of 60 months