Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT02254005
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10-01', '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': '2004-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) of bivatuzumab mertansine', 'timeFrame': 'up to day 21'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'up to day 21'}, {'measure': 'Number of patients with clinically significant findings in laboratory tests', 'timeFrame': 'up to day 21'}, {'measure': 'Number of patients with clinically significant findings in vital signs', 'timeFrame': 'up to day 21'}, {'measure': 'Tumor response rate', 'timeFrame': 'up to 1 year', 'description': 'assessed by 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': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. female patients aged 18 years or older\n2. patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells\n3. patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) 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 on 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 requiring therapy\n5. neuropathy common toxicity criteria (CTC) grade 2 or above\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 four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)\n13. radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial\n14. 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 four weeks before start of therapy or concomitantly with this trial (except for present trial drug)\n17. patients unable to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT02254005', 'briefTitle': 'Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration in Patients With Clinical Benefit', 'orgStudyIdInfo': {'id': '1191.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single dose escalation', 'interventionNames': ['Drug: bivatuzumab mertansine']}], 'interventions': [{'name': 'bivatuzumab mertansine', 'type': 'DRUG', 'armGroupLabels': ['single dose escalation']}]}, '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'}}}}