Status:
UNKNOWN
Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Malignant Skin Melanoma T0
Stage III Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 St...
Detailed Description
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 St...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01168050
Start Date
July 1 2010
End Date
December 1 2013
Last Update
February 8 2011
Active Locations (1)
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1
Hôpital Saint-Louis
Paris, France, 75010