A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread (NICAM)
|Mucosal Lentiginous Melanoma Acral Lentiginous Malignant Melanoma||Drug: nilotinib||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Nilotinib in the Treatment of Patients With c-KIT Mutated Advanced Acral and Mucosal Melanoma|
- Proportion of participants with the c-KIT mutation who remain progression free at 6 months. [ Time Frame: 6 months ]Progression free survival times will be measured from the date of enrolment into the treatment phase until the first date (following start of treatment) of either death or confirmed progressive disease according to RECIST.
- toxicity of treatment [ Time Frame: evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks) ]Treatment related toxicity will be assessed at each clinic visit approximately every 4 weeks whilst the patient continues on study treatment. Study treatment will continue until the patient relapses or is withdrawn from study therapy (on average estimated to be between 4 and 52 weeks).
- response at 12 weeks [ Time Frame: tumours measured at 12 weeks from start of treatment ]Lesions must be measured and or evaluated at 12 weeks in accordance with the Response evaluation criteria in solid tumours (RECIST)
- overall survival [ Time Frame: Expected to be 6 - 12 months (Measured from commencement of treatment until time of death) ]
|Actual Study Start Date:||December 2009|
|Study Completion Date:||December 12, 2016|
|Primary Completion Date:||December 12, 2016 (Final data collection date for primary outcome measure)|
nilotinib 400mgs oral tablets
nilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment
Other Name: Tasigna
NICAM has a two step consent process. Patients diagnosed with advanced acral or mucosal melanoma first consent for study registration and undergo screening tests including testing samples of melanoma tissue for the c-KIT mutation.
Following confirmation of the c-KIT mutation, patients are asked to consent to study entry with continuation of screening. Eligible patients then enter the study and commence taking nilotinib tablets twice a day for as long as clinical benefit is maintained.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395121
|Royal Marsden NHS Foundation Trust|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||James Larkin, MA BM BCh MRCP PhD||Royal Marsden NHS Foundation|