Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer
NCT ID: NCT02605044
Last Updated: 2019-02-11
Study Results
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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TERMINATED
PHASE3
123 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Masitinib + FOLFIRI
masitinib + FOLFIRI
Masitinib (AB1010)
FOLFIRI
Placebo + FOLFIRI
Placebo + FOLFIRI
FOLFIRI
Interventions
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Masitinib (AB1010)
FOLFIRI
Eligibility Criteria
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Inclusion Criteria
* Metastatic disease not amenable to surgical resection
* Patient in second line treatment after progression according to RECIST criteria
* Patient with measurable lesions according to RECIST criteria (version 1.1)
* Patient eligible for a standard second line treatment with FOLFIRI
* Patient with ECOG ≤ 2
* Patient with adequate organ function
* Patient with life expectancy \> 3 months
* Female or male patient ≥ 18
* Patient weight \> 40 kg and BMI \> 18
Exclusion Criteria
* More than 1 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
* Patient with an hepatic involvement \> 50%
* Patient with active central nervous system (CNS) metastasis or history of CNS metastases
* Patient with an active infection
* Patient presenting with cardiac disorders
* Any previous treatment with an investigational agent or chemotherapy or biological agent within four weeks prior to baseline.
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Julien Taieb, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Européen Georges Pompidou, Paris, France
Locations
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Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc
Paris, , France
National Cancer Center, 11 Hospital Drive
Singapore, , Singapore
Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road
London, , United Kingdom
Countries
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Other Identifiers
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AB12006
Identifier Type: -
Identifier Source: org_study_id
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