Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: Masitinib

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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia, 779 00
    • University Hospital Olomouc
• France
  • Rouen, France
    • CHU - Hôpitaux de Rouen
• Russian Federation
  • Omsk, Russian Federation, 644013
    • Omsk Clinical Oncology Dispensary
• Spain
  • Madrid, Spain
    • Hospital Madrid Norte San Chinarro
• United Kingdom
  • London, United Kingdom
    • Hammersmith Hospital Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Masitinib plus FOLFIRI; 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.	Drug: Masitinib; Tyrosine kinase inhibitor; Other Names: AB1010
NO_INTERVENTION: Best Supportive Care; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rates	Survival rate, defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution	Every 24 weeks, assessed up to 60 months
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.	From day of randomization to disease progression or death, whichever came first, assessed up to 60 months

Collaborators and Investigators

• Sponsor: AB Science
• Investigators: Principal Investigator: Julien Taieb, MD, Hôpital Européen Georges Pompidou, Paris, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: June 3, 2018
• First Submitted That Met QC Criteria: June 3, 2018
• First Posted (ACTUAL): June 14, 2018

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

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: AB12010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No