Back to resultsMasitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer Metastatic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Masitinib
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Metastatic
Eligibility Criteria
Inclusion Criteria:
- Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum.
- Patient in third line or fourth line of treatment for metastatic colorectal cancer.
- Patient with measurable lesions according to RECIST criteria (version 1.1).
- Patient with ECOG equal to or less than 2.
- Patient with adequate organ function
- Other inclusion criteria may also apply
Exclusion Criteria:
- Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib.
- More than 3 prior chemotherapy regimens for metastatic colorectal cancer.
- Pregnant, intent to be pregnant, or nursing female patient
- Patient with any chronic inflammatory bowel disease
- Patient treated for a cancer other than colorectal cancer within five years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
- Other exclusion criteria may also apply
Sites / Locations
- University Hospital Olomouc
- Chu - Hopitaux de Rouen
- Omsk Clinical oncology dispensary
- Hospital Madrid Norte San Chinarro
- Hammersmith Hospital Imperial College Healthcare Nhs Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Masitinib plus FOLFIRI
Best Supportive Care
Arm Description
Masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid). Masitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal.
Best Supportive Care (BSC) includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.
Outcomes
Primary Outcome Measures
Overall survival
Overall survival (0S) 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
Survival rates
Survival rate, defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Progression Free Survival (PFS)
Progression Free Survival (PFS) 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 the investigator on CT scan according to RECIST 1.1 criteria.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03556956
Brief Title
Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer
Official Title
Masitinib in Combination With FOLFIRI Versus Masitinib Alone, Versus Best Supportive Care, in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (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
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer
Detailed Description
The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care in third or fourth line treatment of patients with metastatic colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicentre, open-label, randomized, parallel groups, seamless phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid), versus Best Supportive Care in third or fourth line of treatment of patients with metastatic colorectal cancer.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib plus FOLFIRI
Arm Type
Experimental
Arm Description
Masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid).
Masitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal.
Arm Title
Best Supportive Care
Arm Type
No Intervention
Arm Description
Best Supportive Care (BSC) includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Description
Tyrosine kinase inhibitor
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival (0S) 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
Survival rates
Description
Survival rate, defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Time Frame
Every 24 weeks, assessed up to 60 months
Title
Progression Free Survival (PFS)
Description
Progression Free Survival (PFS) 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 the investigator on CT scan according to RECIST 1.1 criteria.
Time Frame
From day of randomization to disease progression or death, whichever came first, assessed up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum.
Patient in third line or fourth line of treatment for metastatic colorectal cancer.
Patient with measurable lesions according to RECIST criteria (version 1.1).
Patient with ECOG equal to or less than 2.
Patient with adequate organ function
Other inclusion criteria may also apply
Exclusion Criteria:
Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib.
More than 3 prior chemotherapy regimens for metastatic colorectal cancer.
Pregnant, intent to be pregnant, or nursing female patient
Patient with any chronic inflammatory bowel disease
Patient treated for a cancer other than colorectal cancer within five years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
Other exclusion criteria may also apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Taieb, MD
Organizational Affiliation
Hôpital Européen Georges Pompidou, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Chu - Hopitaux de Rouen
City
Rouen
Country
France
Facility Name
Omsk Clinical oncology dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Hospital Madrid Norte San Chinarro
City
Madrid
Country
Spain
Facility Name
Hammersmith Hospital Imperial College Healthcare Nhs Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer
We'll reach out to this number within 24 hrs