Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 8:13 PM
Study NCT ID:
NCT01168050
Status:
UNKNOWN
Last Update Posted:
2011-02-08
First Post:
2010-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C498826', 'term': 'nilotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-07', 'studyFirstSubmitDate': '2010-07-21', 'studyFirstSubmitQcDate': '2010-07-21', 'lastUpdatePostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response', 'timeFrame': '6 months', 'description': 'Partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST).'}], 'secondaryOutcomes': [{'measure': 'Disease control', 'timeFrame': '6 months', 'description': 'Complete or partial response or stable disease per Response Evaluation Criteria in Solid Tumors (RECIST).'}, {'measure': 'Objective response', 'timeFrame': '3 months', 'description': 'Partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST).'}, {'measure': 'Metabolic response', 'timeFrame': '6 months', 'description': 'Metabolic response as evaluated by TEP-SCAN'}, {'measure': 'Tolerance', 'timeFrame': '1 year', 'description': 'Tolerance will be evaluated according to National Cancer Institute (NCI) Criteria for Adverse Events, CTCAE v3.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Malignant Skin Melanoma T0', 'stage III unresectable melanomas,', 'or stage IV melanomas with c-KIT mutation', 'or amplification.'], 'conditions': ['Malignant Skin Melanoma T0', 'Stage III Melanoma', 'Stage IV Melanoma', 'Amplification']}, 'descriptionModule': {'briefSummary': 'NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include:\n\n* Disease control rate (complete, partial response and stable disease)\n* Metabolic response\n* Tolerance NCI CTCAE Version 3.0\n* Biomarkers associated to response and disease control.', 'detailedDescription': 'NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification (in case of c-KIT amplification, no B-RAF nor N-Ras mutation should be detected). The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include:\n\n* Disease control rate (complete, partial response and stable disease) according to RECIST\n* Metabolic response rate (TEP-SCAN)\n* Tolerance NCI CTCAE Version 3.0\n* Biomarkers associated to response and disease control (evaluated at M0, M1 and M6). Protein analysis of c-KIT, PI3K, MAPK and STAT signalling pathways as well as PDGFR and Ephrin signalling pathways.\n\nPatients with progressive disease after 3 months therapy will be withdrawn. Patient with stable disease after 3 months will continue Nilotinib until evaluation at 6 months. Patients with stable disease or progressive disease at 6 months will continue Nilotinib until progression.\n\nThe trial has been planned using a one-stage design (Fleming TR) . We considered that a response rate under 7.5% would define the null hypothesis of no efficacy . To detect a response rate of 30% or more with power 90% using a one-sided test at the 0.05 level, 25 patients have to be recruited.\n\nAccrual for 2.5 years total study duration: 3 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically proven melanoma with either c-KIT mutation or C-KIT amplification (without BRAF or NRAS mutation)\n* Unresectable primary or stage III or stage IV melanoma\n* Measurable disease (RECIST)\n* The inclusion of patients with primary tumor or metastasis accessible to sequential biopsies will be favored. If such lesions are present, biopsies are mandatory and not optional\n* No more than 1 previous specific therapy excluding tyrosine kinase inhibitors. 4 weeks wash out will be needed after cytotoxic therapy , 12 weeks wash out after anti -CTLA4 therapy or any immunological treatment\n* No radiotherapy within 4 weeks ; previously irradiated lesion will not be considered as measurable unless progression at inclusion\n* ECOG performance status \\< 2\n* WBC ≥ 3,000/mm³\n* PNN ≥ 1,500/mm³ (G-CSF allowed)\n* platelets ≥ 100,000/mm³\n* Hb ≥ 9.0 g/dL ( transfusions allowed as well as recombinant erythropoetin)\n* Creatinin clearance \\> 40ml/mn\n* Normal kalemia\n* Normal magnesemia\n* Total bilirubin \\<1.5N ; ASAT and ALAT \\<2.5N\n* PT/INR and PTT normal\n* NYHA class \\< 3\n* Signed Written Informed Consent\n* Affiliated to the National Health Insurance\n\nExclusion Criteria:\n\n* Patients refusal\n* Age \\< 18 years\n* Fertile women who do not want or cannot use effective contraception during the study and up to 8 weeks after the end of study\n* Women pregnant or nursing\n* Women with positive pregnancy test at inclusion or before treatment initiation\n* Fertile and sexually active men whose partner are fertile women who do not use effective contraception\n* Clinical and/or radiographic evidence of active cerebral metastases\n* Severe evolutive infection\n* Known HIV infection\n* Concomitant therapy with any other anti-cancer, immunomodulator or immunosuppressing agent or radiotherapy (except palliative care if bone metastases, after acceptance of principal investigator).\n* Previous use of tyrosine kinase inhibitors\n* More than one line of prior systemic therapies of melanoma by anti-cancer agent or immunotherapy.\n* Received experimental treatment within 4 weeks of inclusion\n* Pace-maker\n* Cardiac dysfunction, as evaluated by one of:\n\n * Ejection fraction \\< 45% (less than 28 days from inclusion)\n * Congenital prolonged QT\n * QTc \\> 450 ms\n * Ventricular tachyarrhythmia within the past 6 months\n * Bradycardia at rest \\< 50/mn\n * Major conduction dysfunction\n * Myocardial infarction within the previous 6 months\n * Unstable angina\n* Uncontrolled hypertension\n* Digestive disease that may inhibited NILITINIB absorption\n* Concomitant medication that may increase QT\n* Taking CYP3A4 inhibitors\n* Eating Sevilla oranges (or Sevilla oranges derivates), grapefruit (or grapefruit juice), grapes (or grapes juice), pomegranate (or pomegranate juice)\n* Hereditary galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.'}, 'identificationModule': {'nctId': 'NCT01168050', 'acronym': 'NILOMEL', 'briefTitle': 'Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Phase II Multicentric Uncontrolled National Trial Assessing the Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas , Stage III Unresectable Melanomas, or Stage IV Melanomas With c-KIT Mutation or Amplification.', 'orgStudyIdInfo': {'id': 'P081237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nilotinib', 'interventionNames': ['Drug: Nilotinib']}], 'interventions': [{'name': 'Nilotinib', 'type': 'DRUG', 'description': 'Nilotinib 400 mg twice per day', 'armGroupLabels': ['Nilotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Celeste Lebbe, MD, PhD', 'role': 'CONTACT', 'email': 'celeste.lebbe@sls.aphp.fr'}, {'name': 'Celeste Lebbe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Zakia Idir, PhD', 'role': 'CONTACT', 'email': 'zakia.idir@sls.aphp.fr', 'phone': '+33 1 4484 1747'}], 'overallOfficials': [{'name': 'Celeste Lebbe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Saint-Louis, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zakia Idir', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}