Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-29 @ 6:23 AM
Study NCT ID:
NCT01837095
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2013-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation of POL6326 in Combination With Eribulin in Patients With 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': 'C000624271', 'term': 'balixafortide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer', 'timeFrame': '6 months', 'description': 'Incidence and severity of adverse events and serious adverse events of the combination of POL6326 and eribulin when compared to the adverse event profile of eribulin alone'}], 'secondaryOutcomes': [{'measure': 'Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer', 'timeFrame': '12-24 months', 'description': 'Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Overall survival', 'Progression free survival'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29706375', 'type': 'DERIVED', 'citation': 'Pernas S, Martin M, Kaufman PA, Gil-Martin M, Gomez Pardo P, Lopez-Tarruella S, Manso L, Ciruelos E, Perez-Fidalgo JA, Hernando C, Ademuyiwa FO, Weilbaecher K, Mayer I, Pluard TJ, Martinez Garcia M, Vahdat L, Perez-Garcia J, Wach A, Barker D, Fung S, Romagnoli B, Cortes J. Balixafortide plus eribulin in HER2-negative metastatic breast cancer: a phase 1, single-arm, dose-escalation trial. Lancet Oncol. 2018 Jun;19(6):812-824. doi: 10.1016/S1470-2045(18)30147-5. Epub 2018 Apr 26.'}]}, 'descriptionModule': {'briefSummary': 'POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast.\n* Presence of at least one measurable lesion per RECIST 1.1 criteria\n* Stage IV disease by AJCC criteria (7th edition).\n* HER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio \\< 2.0)\n* Must have had treatment with at least 2 but no more than 3 previous regimens in the metastatic setting. Previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting.\n* At least 21 days from the completion of any previous cytotoxic chemotherapy or biological therapy at time of initiation of POL6326.\n* ECOG performance status \\< 2\n\nExclusion Criteria:\n\n* Previously received eribulin.\n* Peripheral neuropathy \\> Grade 2.\n* Receipt of any other investigational agent within the 28 days prior to Day 1.\n* Receipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim within 14 days prior to Day 1.\n* Radiation therapy within the 14 days prior to Day 1.\n* Severe concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements.\n* History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.\n* Pregnant or breastfeeding.\n* Known HIV positivity on combination antiretroviral therapy; these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy'}, 'identificationModule': {'nctId': 'NCT01837095', 'briefTitle': 'Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Polyphor Ltd.'}, 'officialTitle': 'A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'POL-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POL6326', 'description': 'POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin', 'interventionNames': ['Drug: POL6326']}], 'interventions': [{'name': 'POL6326', 'type': 'DRUG', 'description': 'POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin', 'armGroupLabels': ['POL6326']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64111', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': "St Luke's Cancer Institute", 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine, Division of Oncology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': "'Dartmouth-Hitchcock Medical Center", 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Breast Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University School of Medicine', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08023', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Quiron Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': "Instituto Catalàn de Oncologia L'Hospitalet", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'HGUG Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Cinico Universitario de ValenciaValencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polyphor Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}