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

NCT03556956 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AB12010
• Study Type: interventional
• Target: 219
• Locations: 5 countries
• Sites: 5

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

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survival rates

  Every 24 weeks, assessed up to 60 months

• Progression Free Survival (PFS)

  From day of randomization to disease progression or death, whichever came first, assessed up to 60 months

Study Arms (2)

Masitinib plus FOLFIRI

EXPERIMENTAL

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

Best Supportive Care

NO INTERVENTION

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.

Interventions

Masitinib DRUG

Tyrosine kinase inhibitor

Also known as: AB1010

Masitinib plus FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AB Science: lead

Study Sites (5)

University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

Chu - Hopitaux de Rouen

Rouen, France

Location

Omsk Clinical oncology dispensary

Omsk, 644013, Russia

Location

Hospital Madrid Norte San Chinarro

Madrid, Spain

Location

Hammersmith Hospital Imperial College Healthcare Nhs Trust

London, United Kingdom

Location

MeSH Terms

Interventions

masitinib

Study Officials

• Julien Taieb, MD

  Hôpital Européen Georges Pompidou, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: June 14, 2018
• Study Start: July 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-04

Locations

RU (1); CZ (1); FR (1); GB (1); ES (1)