Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-04-09 @ 4:55 AM
Study NCT ID:
NCT02759250
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and grading of AEs', 'timeFrame': 'measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378', 'description': 'Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile of ARGX110 by Cmax', 'timeFrame': 'measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378', 'description': 'Change from baseline in Measurement of drug concentration in the blood'}, {'measure': 'Pharmacokinetic profile of ARGX110 by AUC', 'timeFrame': 'measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378', 'description': 'Change in Measurement of drug concentration in the blood'}, {'measure': 'Biomarkers CD70 immunohistochemistry (IHC)', 'timeFrame': 'measured at Screening, Day 42, and thereafter every 42 days until day Day 378', 'description': 'Change in Measurement of concentration in tumor tissue'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'To characterize the safety profile of ARGX-110 administered as mono- or combination therapy to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ≥18 years.\n* Written informed consent prior to any study-related procedure\n* Willing and able to comply with protocol-specified procedures and scheduled evaluations\n* Pathological diagnosis of nasopharyngeal carcinoma (NPC)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1or 2\n* Absolute neutrophil count (ANC) \\> 0.5 x 109/L\n* Haemoglobin \\> 80 g/L\n* Platelet count ≥ 50 x 109/L\n* Total bilirubin ≤ 2 x the upper limit of normal (ULN)\n* Alanine transaminase (ALT) ≤ 5 x ULN\n* Serum creatinine ≤ 2 x ULN\n\nExclusion criteria:\n\n* History or clinical evidence of neoplastic central nervous system (CNS) involvement. Note: Irradiated brain metastases that have been stable for \\> 1 month and do not require systemic glucocorticoid administration are allowed\n* Major surgery within 4 weeks of ARGX-110 first dose administration\n* Unresolved grade 3 or 4 toxicity from prior therapy (except mucositis from local radiation therapy).\n* Active, untreated viral, bacterial, or systemic fungal infection\n* Childbearing potential unless using an adequate measure of contraception\n* Pregnancy or lactation. History of hypersensitivity to recombinant proteins\n* Any clinical finding, including psychiatric and behavioural problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study'}, 'identificationModule': {'nctId': 'NCT02759250', 'briefTitle': 'A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': 'A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)', 'orgStudyIdInfo': {'id': 'ARGX-110-1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'adjuvant monotherapy', 'description': 'ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles', 'interventionNames': ['Drug: ARGX-110']}, {'type': 'EXPERIMENTAL', 'label': 'metastatic/recurrent monotherapy', 'description': 'ARGX-110 5mg/kg once every three weeks until disease progression', 'interventionNames': ['Drug: ARGX-110']}, {'type': 'EXPERIMENTAL', 'label': 'metastatic/recurrent combination therapy', 'description': 'ARGX-110 5mg/kg once every three weeks plus chemotherapy until disease progression. The choice of the chemotherapy agents is limited to: cisplatin, carboplatin, 5-fluorouracil, gemcitabine and paclitaxel.', 'interventionNames': ['Drug: ARGX-110']}], 'interventions': [{'name': 'ARGX-110', 'type': 'DRUG', 'armGroupLabels': ['adjuvant monotherapy', 'metastatic/recurrent combination therapy', 'metastatic/recurrent monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZG - Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Sylvie Rottey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZG - Universitair Ziekenhuis Gent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'argenx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}