A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread (NCT01395121) | Clinical Trial Compass
CompletedPhase 2
A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread
United Kingdom29 participantsStarted 2009-12
Plain-language summary
The aim of this study is to see if a drug called nilotinib (Tasigna®) is effective in the treatment of patients with a rare group of acral and mucosal melanomas that have a change (mutation) in a protein called cKIT. Nilotinib interferes with signalling inside cells with this mutation and it is believed that this may lead to shrinkage of tumours. Acral melanomas are found on the palms and soles and mucosal melanomas start inside body cavities rather than on the skin.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with c-KIT mutated histologically proven advanced mucosal or acral melanoma in which the mutation is not known to be associated with nilotinib resistance.
. Advanced mucosal and acral melanoma defined as unresectable locally advanced or metastatic disease
. The presence of one or more clinically or radiologically measurable lesions at least 10mm in size
. Age 18 or greater
. ECOG performance status 0, 1 or 2
. Life expectancy greater than 12 weeks
. At least 14 days since any major surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with the c-KIT mutation who remain progression free at 6 months.
Timeframe: 6 months
Trial details
NCT IDNCT01395121
SponsorInstitute of Cancer Research, United Kingdom
. The capacity to understand the patient information sheet and ability to provide written informed consent
Exclusion criteria
. Intracranial disease, unless there has been radiological evidence of stable intracranial disease \> 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
. Women who are pregnant, nursing, or planning to become pregnant during the course of the trial
. Men who plan to father a child during the course of the trial
. Use of any investigational drug within 30 days prior to screening (both cancer and non cancer treatments)
. Use of herbal or chinese medication
. Use of therapeutic coumarin derivatives (ie warfarin, acenocoumarol, phenprocoumon)
. Significant cardiac disease including patients who have or who are at significant risk of developing prolongation of QTc