Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT01168050
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01168050
Study Brief:
Protocol Section:
NCT01168050