Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-30 @ 11:15 PM
Study NCT ID:
NCT00735332
Status:
TERMINATED
Last Update Posted:
2010-08-05
First Post:
2008-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], '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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'whyStopped': 'License termination.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-04', 'studyFirstSubmitDate': '2008-08-13', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).', 'timeFrame': 'Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)'}], 'secondaryOutcomes': [{'measure': 'To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma', 'timeFrame': 'Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Metastatic Melanoma', 'Phase II', 'Skin Cancer'], 'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous)\n* First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them)\n* Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1\n* Age ≥ 18 years\n* ECOG ≤ 2\n* Normal organ and marrow function as defined below:\n\n * Leukocytes ≥2.5 x 109/L\n * Absolute neutrophil count ≥1.5 x 109/L\n * Platelets ≥100 x 109/L\n * Hemoglobin ≥100 g/L (10g/dL)\n * Total bilirubin ≤1.5 X institutional ULN\n * AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN\n * Creatinine ≤1.5 X institutional ULN\n\nExclusion Criteria:\n\n* Patients with a life expectancy ≤ 16 weeks\n* Patients with ocular melanoma\n* Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1\n* Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues\n* Patients with a documented history of HIV, active hepatitis B or C infection\n* Female patients who are pregnant or lactating\n* Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted)\n* Patients with grade ≥2 peripheral neuropathy (CTCAE criteria)\n* Patients in whom a proper central line cannot be established'}, 'identificationModule': {'nctId': 'NCT00735332', 'briefTitle': 'Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Thallion Pharmaceuticals'}, 'officialTitle': 'A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'TLN-232-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Arm', 'interventionNames': ['Drug: TLN-232']}], 'interventions': [{'name': 'TLN-232', 'type': 'DRUG', 'otherNames': ['Formerly CAP-232'], 'description': '21 day continuous IV administration of TLN-232 followed by a 7-day recovery period', 'armGroupLabels': ['Single-Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Notre-Dame du CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'David Hogg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Hospital, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thallion Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Didier Reymond, MD / Executive Vice-President Clinical Development', 'oldOrganization': 'Thallion Pharmaceuticals Inc.'}}}}