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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Masitinib
Gemcitabine
Placebo
Sponsored by
AB Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, tyrosine kinase inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalo-universitaire de Beni Messous
  • Institut Sainte Catherine
  • City Oncology Clinic
  • Complejo Hospitalario Universitario de Santiago
  • Lviv State Oncological Regional Treatment and Diagnostic Center
  • University Hospital Coventry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Masitinib & gemcitabine

Placebo & gemcitabine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 18, 2015
Last Updated
December 7, 2020
Sponsor
AB Science
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1. Study Identification

Unique Protocol Identification Number
NCT02490488
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, tyrosine kinase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Masitinib & gemcitabine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo & gemcitabine
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
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.
Time Frame
From day of randomization to death, assessed for a maximum of 60 months
Secondary Outcome Measure Information:
Title
Overall Progression Free Survival (PFS)
Description
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.
Time Frame
From day of randomization to disease progression or death, assessed for a maximum of 60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria: 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). Patient with adequate organ function per laboratory tests evaluations Main exclusion criteria: Patient intolerant to gemcitabine Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2) Pregnant or nursing female patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Grenier, Dr
Organizational Affiliation
AB Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalo-universitaire de Beni Messous
City
Algiers
ZIP/Postal Code
16340
Country
Algeria
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
City Oncology Clinic
City
St.-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago
ZIP/Postal Code
15706
Country
Spain
Facility Name
Lviv State Oncological Regional Treatment and Diagnostic Center
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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