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

NCT ID: NCT03556956

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Metastatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Masitinib

Intervention Type DRUG

Tyrosine kinase inhibitor

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Masitinib

Tyrosine kinase inhibitor

Intervention Type DRUG

Other Intervention Names

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AB1010

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien Taieb, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges Pompidou, Paris, France

Locations

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University Hospital Olomouc

Olomouc, , Czechia

Site Status

Chu - Hopitaux de Rouen

Rouen, , France

Site Status

Omsk Clinical oncology dispensary

Omsk, , Russia

Site Status

Hospital Madrid Norte San Chinarro

Madrid, , Spain

Site Status

Hammersmith Hospital Imperial College Healthcare Nhs Trust

London, , United Kingdom

Site Status

Countries

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Czechia France Russia Spain United Kingdom

Other Identifiers

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AB12010

Identifier Type: -

Identifier Source: org_study_id