Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-15 @ 2:17 AM
Study NCT ID:
NCT02254018
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2014-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
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': 'C519271', 'term': 'bivatuzumab mertansine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) of bivatuzumab mertansine', 'timeFrame': 'up to day 21'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'up to day 21', 'description': 'grading according to the common toxicity criteria (CTC)'}, {'measure': 'Number of patients with clinically significant changes in laboratory parameters', 'timeFrame': 'up to day 21'}, {'measure': 'Number of patients with clinically significant changes in vital signs', 'timeFrame': 'up to day 21'}, {'measure': 'Tumor response', 'timeFrame': 'up to 1 year', 'description': 'according to the response evaluation criteria in solid tumours (RECIST)'}, {'measure': 'Concentration of bivatuzumab mertansine', 'timeFrame': 'up to day 21'}, {'measure': 'Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)', 'timeFrame': 'up to day 21'}, {'measure': 'Number of patients with development of human anti-human antibodies (HAHA)', 'timeFrame': 'up to day 21'}]}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms']}, 'descriptionModule': {'briefSummary': 'maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male and female patients aged 18 years or older\n2. patients with histologically confirmed squamous cell carcinoma of the head and neck\n3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments\n4. measurable tumour deposits by one or more radiological techniques (MRI, CT)\n5. life expectancy of at least 6 months\n6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2\n7. patients must have given written informed consent (which must be consistent with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)\n\nExclusion Criteria:\n\n1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs\n2. known secondary malignancy requiring therapy\n3. active infectious disease\n4. brain metastases\n5. neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)\n6. absolute neutrophil count less than 1,500/mm3\n7. platelet count less than 100,000/mm3\n8. bilirubin greater than 1.5 mg/dl (\\> 26 μmol/L, système internationale (SI) unit equivalent)\n9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal\n10. serum creatinine greater than 1.5 mg/dl (\\> 132 μmol/L, SI unit equivalent)\n11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug\n12. chemo- or immunotherapy within the past three weeks prior to treatment with the trial drug or during the trial\n13. radiotherapy to head and neck region within the past four weeks before inclusion or during the trial\n14. men and women who are sexually active and unwilling to use a medically acceptable method of contraception\n15. pregnancy or lactation\n16. treatment with other investigational drugs or participation in another clinical trial within the past three weeks before start of therapy or concomitantly with this trial\n17. patients unable to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT02254018', 'briefTitle': 'Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit', 'orgStudyIdInfo': {'id': '1191.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bivatuzumab mertansine', 'description': 'single dose escalation', 'interventionNames': ['Drug: bivatuzumab mertansine']}], 'interventions': [{'name': 'bivatuzumab mertansine', 'type': 'DRUG', 'armGroupLabels': ['bivatuzumab mertansine']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}