Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-30 @ 6:37 AM
Study NCT ID:
NCT01046266
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2009-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569293', 'term': 'imgatuzumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immune cell infiltration head and neck squamous cell cancer (HNSCC)', 'timeFrame': 'through study completion or early study discontinuation'}], 'secondaryOutcomes': [{'measure': 'pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels', 'timeFrame': 'through study completion or early study discontinuation'}, {'measure': 'safety and efficacy: AEs, laboratory parameters, tumour assessments', 'timeFrame': 'through study completion or early study discontinuation'}]}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '28950289', 'type': 'DERIVED', 'citation': 'Temam S, Spicer J, Farzaneh F, Soria JC, Oppenheim D, McGurk M, Hollebecque A, Sarini J, Hussain K, Soehrman Brossard S, Manenti L, Evers S, Delmar P, Di Scala L, Mancao C, Feuerhake F, Andries L, Ott MG, Passioukov A, Delord JP. An exploratory, open-label, randomized, multicenter study to investigate the pharmacodynamics of a glycoengineered antibody (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2827-2835. doi: 10.1093/annonc/mdx489.'}]}, 'descriptionModule': {'briefSummary': 'This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is \\<50.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>/=18 years of age\n* squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx\n\nExclusion Criteria:\n\n* carcinoma of nasal cavity, paranasal sinus and nasopharynx\n* recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx\n* known positivity for HIV, hepatitis B and/or hepatitis C infection'}, 'identificationModule': {'nctId': 'NCT01046266', 'briefTitle': 'A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'BP22350'}, 'secondaryIdInfos': [{'id': '2009-012656-25'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: RO5083945']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: cetuximab']}], 'interventions': [{'name': 'RO5083945', 'type': 'DRUG', 'description': '700mg iv weekly', 'armGroupLabels': ['A']}, {'name': 'cetuximab', 'type': 'DRUG', 'description': '400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '20162', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '41013', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}