Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT01913067
Status:
WITHDRAWN
Last Update Posted:
2014-07-24
First Post:
2013-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552428', 'term': 'cabazitaxel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Scientific rationale is deemed obsolete. Funders lost interest in the trial.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-23', 'studyFirstSubmitDate': '2013-07-18', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of brain lesions.', 'timeFrame': 'week 6', 'description': 'Objective response defined as a \\>= 50% volumetric reduction of brain lesions in the absence of increasing steroid use and progressive neurologic symptoms.'}], 'secondaryOutcomes': [{'measure': 'Time to whole brain irradiation or radiosurgery', 'timeFrame': 'every 6 weeks until disease progression.', 'description': 'Determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery'}, {'measure': 'Time to developing neurological symptoms.', 'timeFrame': 'every 6 weeks until disease progression.', 'description': 'Determine the effect of cabazitaxel on the time to developing neurological symptoms'}, {'measure': 'Time to progression in the brain', 'timeFrame': 'every 6 weeks until disease progression.', 'description': 'Determine the effect of cabazitaxel on the time to disease progression in the brain.'}, {'measure': 'Time to progression extra-cranial', 'timeFrame': 'every 6 weeks until disease progression.', 'description': 'Determine the effect of cabazitaxel on the time to disease progression outside the brain'}, {'measure': 'Toxicity', 'timeFrame': 'every 3 weeks until 30 days after last treatment administration.', 'description': 'Determine the safety of cabazitaxel'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['brain metastasis', 'breast cancer', 'HER2 negative', 'NSCLC'], 'conditions': ['Brain Metastasis', 'Breast Cancer', 'Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC).\n\nOBJECTIVES:\n\nPrimary:\n\nThe purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis who were not previously treated with whole brain irradiation or require immediate brain irradiation.\n\nSecondary:\n\n* To determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery\n* To determine the effect of cabazitaxel on the time to developing neurological symptoms\n* To determine the effect of cabazitaxel on the time to disease progression in the brain\n* To determine the effect of cabazitaxel on the time to disease progression outside the brain. This will be evaluated separately for the breast and NSCLC cohorts To determine the objective extra-cranial response (if applicable). This will be evaluated separately in the breast and NSCLC cohorts\n* To determine the safety of cabazitaxel', 'detailedDescription': 'This is a single arm, prospective trial using a 2-stage Simon design, in which eligible patients will receive intravenous cabazitaxel for two cycles followed by response evaluation. Based on the pre-specified criteria of response (intra-cranial, patient will be allowed to continue on study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Age\\>18, ECOG 0-1\n* Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC\n* In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).\n* In patients with breast cancer, known estrogen and progesterone receptor status.\n* Evidence of measurable disease in the brain (at least 1cm)\n* Stable or decreasing dosage of steroids for 7 days prior to baseline MRI.\n* No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE) score ≥ 25/30.\n* No more than 4 prior lines of systemic chemotherapy in the metastatic setting\n* Adequate hematopoietic function defined as:\n\n * Hemoglobin ≥ 9.0g/dL\n * Absolute neutrophilic count ≥ 1.5 x 109L\n * Platelet count ≥ 100 x 109L\n* Adequate hepatic function defined as:\n\n * AST ≤ 2.5 x upper limit of normal (ULN)\n * ALT ≤ 2.5 x ULN\n * Total bilirubin ≤ 1.0 x ULN\n* Adequate renal function defined as serum creatinine ≤ 1.5 x ULN. If creatinine ranges from 1.0 - 1.5 x ULN, creatinine clearance determined by CKD-EPI formula should be calculated and only patients with clearance \\>60 mL/min are eligible\n* Adequate contraceptive method in patients with child-bearing potential.\n\nExclusion Criteria:\n\n* History of prior whole brain irradiation\n* Progressive neurological symptoms requiring immediate brain irradiation\n* Pregnancy or lactation\n* History of hypersensitivity reaction to taxanes\n* History of hypersensitivity to polysorbate 80 containing agents\n* Current or planned treatment with strong inhibitors or inducers of cytochrome P450.\n* Less than 3 weeks since the last treatment of chemotherapy, biological therapy, and/or immunotherapy\n* Leptomeningeal carcinomatosis\n* Contra-indication to contrast-enhanced MRI'}, 'identificationModule': {'nctId': 'NCT01913067', 'acronym': 'CRANIAL', 'briefTitle': 'Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': 'A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CE2100'}, 'secondaryIdInfos': [{'id': '2012-005194-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabazitaxel', 'description': 'Eligible patients will receive intravenous 25mg/m2 cabazitaxel every 3 weeks. Contrast-enhanced whole brain MRI will be performed every two cycles. Patients who show ≥50% volumetric reduction in the size of the brain lesion(s) will continue on cabazitaxel until disease progression or unacceptable toxicity. Patients who show evidence of disease progression and/or developed progressive neurological symptoms will be taken off study and offered whole brain irradiation. Patients who do not meet both criteria can have the choice either to continue on study drug or to be taken off study according to the investigator discretion.', 'interventionNames': ['Drug: Cabazitaxel', 'Procedure: Contrast-enhanced whole brain MRI']}], 'interventions': [{'name': 'Cabazitaxel', 'type': 'DRUG', 'otherNames': ['Jevtana'], 'description': 'Intravenous, 25 mg/m2 every 3 weeks', 'armGroupLabels': ['Cabazitaxel']}, {'name': 'Contrast-enhanced whole brain MRI', 'type': 'PROCEDURE', 'description': 'Evaluation of the volumetric reduction in the size of the brain lesion(s).', 'armGroupLabels': ['Cabazitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Ahmad Awada, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute Jules Bordet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}