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

December 7, 2020 updated by: AB Science

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria, 16340
        • Centre hospitalo-universitaire de Beni Messous
  • France
      • Avignon, France, 84000
        • Institut Sainte Catherine
  • Russian Federation
      • St.-Petersburg, Russian Federation, 198255
        • City Oncology Clinic
  • Spain
      • Santiago, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
  • Ukraine
      • Lviv, Ukraine, 79031
        • Lviv State Oncological Regional Treatment and Diagnostic Center
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Masitinib
Other Names:
  • AB1010
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.
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Placebo
Other Names:
  • Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From day of randomization to death, assessed for a maximum of 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From day of randomization to disease progression or death, assessed for a maximum of 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Investigators

  • Principal Investigator: Julien Grenier, Dr, AB Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB12008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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