Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT03556956
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2018-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C526575', 'term': 'masitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'dispFirstSubmitDate': '2020-12-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2018-06-03', 'dispFirstSubmitQcDate': '2020-12-07', 'studyFirstSubmitQcDate': '2018-06-03', 'dispFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From day of randomization to death, assessed for a maximum of 60 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Survival rates', 'timeFrame': 'Every 24 weeks, assessed up to 60 months', 'description': 'Survival rate, defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From day of randomization to disease progression or death, whichever came first, assessed up to 60 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Metastatic']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum.\n* Patient in third line or fourth line of treatment for metastatic colorectal cancer.\n* Patient with measurable lesions according to RECIST criteria (version 1.1).\n* Patient with ECOG equal to or less than 2.\n* Patient with adequate organ function\n* Other inclusion criteria may also apply\n\nExclusion Criteria:\n\n* Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib.\n* More than 3 prior chemotherapy regimens for metastatic colorectal cancer.\n* Pregnant, intent to be pregnant, or nursing female patient\n* Patient with any chronic inflammatory bowel disease\n* 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.\n* Other exclusion criteria may also apply'}, 'identificationModule': {'nctId': 'NCT03556956', 'briefTitle': 'Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Science'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AB12010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Masitinib plus FOLFIRI', 'description': 'Masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid).\n\nMasitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal.', 'interventionNames': ['Drug: Masitinib']}, {'type': 'NO_INTERVENTION', 'label': 'Best Supportive Care', 'description': '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': [{'name': 'Masitinib', 'type': 'DRUG', 'otherNames': ['AB1010'], 'description': 'Tyrosine kinase inhibitor', 'armGroupLabels': ['Masitinib plus FOLFIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '779 00', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Chu - Hopitaux de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '644013', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Omsk Clinical oncology dispensary', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Madrid Norte San Chinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital Imperial College Healthcare Nhs Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Julien Taieb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Européen Georges Pompidou, Paris, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}