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

Colorectal Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556956
• Other study ID #: AB12010
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2015
• 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Masitinib
Tyrosine kinase inhibitor

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc
France	Chu - Hopitaux de Rouen	Rouen
Russian Federation	Omsk Clinical oncology dispensary	Omsk
Spain	Hospital Madrid Norte San Chinarro	Madrid
United Kingdom	Hammersmith Hospital Imperial College Healthcare Nhs Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

Czechia,  France,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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