Stage IV Melanoma Clinical Trial
— NILOMELOfficial title:
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.
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:
- Disease control rate (complete, partial response and stable disease)
- Metabolic response
- Tolerance NCI CTCAE Version 3.0
- Biomarkers associated to response and disease control.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with histologically proven melanoma with either c-KIT mutation or C-KIT amplification (without BRAF or NRAS mutation) - Unresectable primary or stage III or stage IV melanoma - Measurable disease (RECIST) - 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 - 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 - No radiotherapy within 4 weeks ; previously irradiated lesion will not be considered as measurable unless progression at inclusion - ECOG performance status < 2 - WBC = 3,000/mm³ - PNN = 1,500/mm³ (G-CSF allowed) - platelets = 100,000/mm³ - Hb = 9.0 g/dL ( transfusions allowed as well as recombinant erythropoetin) - Creatinin clearance > 40ml/mn - Normal kalemia - Normal magnesemia - Total bilirubin <1.5N ; ASAT and ALAT <2.5N - PT/INR and PTT normal - NYHA class < 3 - Signed Written Informed Consent - Affiliated to the National Health Insurance Exclusion Criteria: - Patients refusal - Age < 18 years - Fertile women who do not want or cannot use effective contraception during the study and up to 8 weeks after the end of study - Women pregnant or nursing - Women with positive pregnancy test at inclusion or before treatment initiation - Fertile and sexually active men whose partner are fertile women who do not use effective contraception - Clinical and/or radiographic evidence of active cerebral metastases - Severe evolutive infection - Known HIV infection - Concomitant therapy with any other anti-cancer, immunomodulator or immunosuppressing agent or radiotherapy (except palliative care if bone metastases, after acceptance of principal investigator). - Previous use of tyrosine kinase inhibitors - More than one line of prior systemic therapies of melanoma by anti-cancer agent or immunotherapy. - Received experimental treatment within 4 weeks of inclusion - Pace-maker - Cardiac dysfunction, as evaluated by one of: - Ejection fraction < 45% (less than 28 days from inclusion) - Congenital prolonged QT - QTc > 450 ms - Ventricular tachyarrhythmia within the past 6 months - Bradycardia at rest < 50/mn - Major conduction dysfunction - Myocardial infarction within the previous 6 months - Unstable angina - Uncontrolled hypertension - Digestive disease that may inhibited NILITINIB absorption - Concomitant medication that may increase QT - Taking CYP3A4 inhibitors - Eating Sevilla oranges (or Sevilla oranges derivates), grapefruit (or grapefruit juice), grapes (or grapes juice), pomegranate (or pomegranate juice) - Hereditary galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Saint-Louis | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response | Partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST). | 6 months | No |
Secondary | Disease control | Complete or partial response or stable disease per Response Evaluation Criteria in Solid Tumors (RECIST). | 6 months | No |
Secondary | Objective response | Partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST). | 3 months | No |
Secondary | Metabolic response | Metabolic response as evaluated by TEP-SCAN | 6 months | No |
Secondary | Tolerance | Tolerance will be evaluated according to National Cancer Institute (NCI) Criteria for Adverse Events, CTCAE v3.0 | 1 year | Yes |
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