Clinical trial NCT03556956: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer Metastatic
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: From day of randomization to death, assessed for a maximum of 60 months
Secondary outcomes:
measure: Survival rates
timeFrame: Every 24 weeks, assessed up to 60 months
measure: Progression Free Survival (PFS)
timeFrame: From day of randomization to disease progression or death, whichever came first, assessed up to 60 months
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Rouen
country: France
facility: Chu - Hopitaux de Rouen
city: Omsk
country: Russian Federation
facility: Omsk Clinical oncology dispensary
city: Madrid
country: Spain
facility: Hospital Madrid Norte San Chinarro
city: London
country: United Kingdom
facility: Hammersmith Hospital Imperial College Healthcare Nhs Trust
Study officials:
affiliation: Hôpital Européen Georges Pompidou, Paris, France
name: Julien Taieb, MD
role: PRINCIPAL_INVESTIGATOR
References: