Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-02-25 @ 3:01 AM
Study NCT ID:
NCT02442466
Status:
TERMINATED
Last Update Posted:
2015-05-20
First Post:
2015-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Difficulties to recruit on time the required patient population.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2015-04-26', 'studyFirstSubmitQcDate': '2015-05-10', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumour response by size measurement and histological examination', 'timeFrame': '3 to14 days'}], 'secondaryOutcomes': [{'measure': 'Measuring changes in tumor cell proliferation by histological analyses using Ab staining', 'timeFrame': '3 to 14 days'}, {'measure': 'Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining', 'timeFrame': '3 to 14 days'}, {'measure': 'Evaluation of changes in blood vessels formation by histological examination using Ab staining', 'timeFrame': '3 to 14 days'}, {'measure': 'Evaluation of changes in immune cell infiltration by histological examination using Ab staining', 'timeFrame': '3 to 14 days'}]}, 'conditionsModule': {'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '8632985', 'type': 'BACKGROUND', 'citation': 'Lahav R, Ziller C, Dupin E, Le Douarin NM. Endothelin 3 promotes neural crest cell proliferation and mediates a vast increase in melanocyte number in culture. Proc Natl Acad Sci U S A. 1996 Apr 30;93(9):3892-7. doi: 10.1073/pnas.93.9.3892.'}, {'pmid': '9826680', 'type': 'BACKGROUND', 'citation': 'Lahav R, Dupin E, Lecoin L, Glavieux C, Champeval D, Ziller C, Le Douarin NM. Endothelin 3 selectively promotes survival and proliferation of neural crest-derived glial and melanocytic precursors in vitro. Proc Natl Acad Sci U S A. 1998 Nov 24;95(24):14214-9. doi: 10.1073/pnas.95.24.14214.'}, {'pmid': '10500205', 'type': 'BACKGROUND', 'citation': 'Lahav R, Heffner G, Patterson PH. An endothelin receptor B antagonist inhibits growth and induces cell death in human melanoma cells in vitro and in vivo. Proc Natl Acad Sci U S A. 1999 Sep 28;96(20):11496-500. doi: 10.1073/pnas.96.20.11496.'}, {'pmid': '15604257', 'type': 'BACKGROUND', 'citation': 'Lahav R, Suva ML, Rimoldi D, Patterson PH, Stamenkovic I. Endothelin receptor B inhibition triggers apoptosis and enhances angiogenesis in melanomas. Cancer Res. 2004 Dec 15;64(24):8945-53. doi: 10.1158/0008-5472.CAN-04-1510.'}, {'pmid': '15906230', 'type': 'BACKGROUND', 'citation': 'Lahav R. Endothelin receptor B is required for the expansion of melanocyte precursors and malignant melanoma. Int J Dev Biol. 2005;49(2-3):173-80. doi: 10.1387/ijdb.041951rl.'}, {'pmid': '26330458', 'type': 'DERIVED', 'citation': 'Wouters J, Hunger RE, Garrod T, Dubuis B, Hunziker T, van den Oord JJ, Lahav-le Coutre R. First-in-Human Proof-of-Concept Study: Intralesional Administration of BQ788, an Endothelin Receptor B Antagonist, to Melanoma Skin Metastases. Oncologist. 2015 Oct;20(10):1121-2. doi: 10.1634/theoncologist.2015-0139. Epub 2015 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written Informed consent\n* Histologically confirmed melanoma\n* Disease stage III or IV\n* At least 2 injectable and surgically removable cutaneous metastasis\n* Age \\> 18 years\n* Clinically stable medical condition\n\nExclusion Criteria:\n\n* Primary ocular melanoma\n* Symptomatic intracranial melanoma\n* History of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (HIV) disease\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT02442466', 'briefTitle': 'Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'MelCure SA'}, 'orgStudyIdInfo': {'id': 'MelCure'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endothelin receptor B inhibitor BQ-788', 'description': 'Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788)', 'interventionNames': ['Drug: Endothelin Receptor B inhibitor BQ788']}, {'type': 'EXPERIMENTAL', 'label': 'PBS', 'description': 'Intra-lesion administration of vehicle', 'interventionNames': ['Drug: PBS']}], 'interventions': [{'name': 'Endothelin Receptor B inhibitor BQ788', 'type': 'DRUG', 'armGroupLabels': ['Endothelin receptor B inhibitor BQ-788']}, {'name': 'PBS', 'type': 'DRUG', 'armGroupLabels': ['PBS']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MelCure SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'California Institute of Technology', 'class': 'OTHER'}, {'name': 'University of Bern', 'class': 'OTHER'}, {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}