Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-03-09 @ 4:09 AM
Study NCT ID:
NCT02211859
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2014-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518477', 'term': 'BI 2536'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2014-08-07', 'studyFirstSubmitQcDate': '2014-08-07', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)', 'timeFrame': 'up to 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of patients with drug-related adverse events', 'timeFrame': 'up to 24 days after last drug administration', 'description': 'according to common terminology criteria for adverse events (CTCAE) 3.0'}, {'measure': 'Number of patients with abnormal laboratory findings', 'timeFrame': 'up to 24 days after last drug administration'}, {'measure': 'Change in Eastern Cooperative Oncology Group (ECOG) performance score', 'timeFrame': 'baseline, up to 24 days after last drug administration'}, {'measure': 'Number of patients with clinically significant changes in vital signs', 'timeFrame': 'up to 24 days after last drug administration'}, {'measure': 'Number of patients with objective tumor response', 'timeFrame': 'up to 24 days after last drug administration'}, {'measure': 'Cmax (maximum concentration of the analyte in plasma)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 'tmax (time from dosing to maximum concentration)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 'AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': '%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 'λz (terminal rate constant in plasma)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 't1/2 (terminal half-life of the analyte in plasma)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 'MRT (mean residence time of the analyte in the body after intravenous administration)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 'CL (total clearance of the analyte in the plasma after intravascular administration)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 'Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)', 'timeFrame': 'up to 264 hours after drug administration'}, {'measure': 'Vss (apparent volume of distribution at steady state following intravascular administration)', 'timeFrame': 'up to 264 hours after drug administration'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment\n* Evaluable tumour deposits\n* Age 18 years or older\n* Life expectancy of at least six months\n* Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation\n* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2\n* Full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies\n\nExclusion Criteria:\n\n* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol\n* Pregnancy or breastfeeding\n* Active infectious disease\n* Known brain metastases\n* Second malignancy requiring therapy\n* Absolute neutrophil count less than 1500/mm3\n* Platelet count less than 100 000/mm3\n* Bilirubin greater than 1.5 mg/dl (\\> 26 μmol/L)\n* Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)\n* Serum creatinine greater than 1.5 mg/dl (\\> 132 μmol/L)\n* Women and men who are sexually active and unwilling to use a medically acceptable method of contraception\n* 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)'}, 'identificationModule': {'nctId': 'NCT02211859', 'briefTitle': 'Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Phase I Repeated Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit', 'orgStudyIdInfo': {'id': '1216.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 2536', 'description': 'single escalating dose, followed by repeated administration in patients with clinical benefit', 'interventionNames': ['Drug: BI 2536']}], 'interventions': [{'name': 'BI 2536', 'type': 'DRUG', 'armGroupLabels': ['BI 2536']}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.', 'ipdSharing': 'YES', 'description': 'Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nFurthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.', 'accessCriteria': 'For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor\'s publication plan); 2. and upon signing of a legal agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}