A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cance... | Not Recruiting
A Trial Looking at Nilotinib to Tre... | Not Recruiting
A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread
NICAM

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Medical Conditions
  • Mucosal Lentiginous Melanoma
  • Acral Lentiginous Malignant Melanoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01395121

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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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : nilotinib

Study Arm Groups : nilotinib

Intervention Type
See Interventions above
Primary Outcome Measures
    Proportion of participants with the c-KIT mutation who remain progression free at 6 months.; 6 months
Secondary Outcome Measures
    toxicity of treatment; evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks); response at 12 weeks; tumours measured at 12 weeks from start of treatment; overall survival; Expected to be 6 - 12 months (Measured from commencement of treatment until time of death)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
24
Participant Inclusion Criteria
    Inclusion Criteria:

    1. 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.

    2. Advanced mucosal and acral melanoma defined as unresectable locally advanced or metastatic disease

    3. The presence of one or more clinically or radiologically measurable lesions at least 10mm in size

    4. Age 18 or greater

    5. ECOG performance status 0, 1 or 2

    6. Life expectancy greater than 12 weeks

    7. At least 14 days since any major surgery

    8. The capacity to understand the patient information sheet and ability to provide written informed consent

    9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

    10. Women must not be pregnant or lactating with no intention of pregnancy during study treatment. Women of child bearing potential must have a negative serum pregnancy test prior to study entry (even if surgically sterilised). Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 6 months after receiving the last study treatment

    11. Serum alanine transaminase (ALT) or serum aspartate aminotransferase ≤2.5 x upper limit of normal (ULN) and total serum bilirubin ≤1.5 x ULN

    12. Serum creatinine ≤1.5 x ULN

    13. Serum lipase and amylase <1.5 x ULN

    14. Haemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.5 x 109/L, platelets ≥100 x 109/L

    15. Prothrombin time (PT) ≤1.5 x ULN

    16. Able to swallow and retain oral medication.

    Exclusion Criteria:

    1. 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

    2. Women who are pregnant, nursing, or planning to become pregnant during the course of the trial

    3. Men who plan to father a child during the course of the trial

    4. Use of any investigational drug within 30 days prior to screening (both cancer and non cancer treatments)

    5. Use of herbal or chinese medication

    6. Use of therapeutic coumarin derivatives (ie warfarin, acenocoumarol, phenprocoumon)

    7. Significant cardiac disease including patients who have or who are at significant risk of developing prolongation of QTc

    8. Severe and/or uncontrolled medical disease

    9. Known chronic liver disease

    10. Past medical history of chronic pancreatitis

    11. Known HIV infection

    12. Previous radiotherapy to 25% or more of the bone marrow

    13. Radiation therapy in the 4 weeks prior to study entry

    14. Prior exposure to a tyrosine kinase inhibitor

    15. Known lactose intolerance

    16. Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn's disease or ulcerative colitis).
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase II Trial of Nilotinib in the Treatment of Patients With c-KIT Mutated Advanced Acral and Mucosal Melanoma
EudraCT Number
Not available for this trial
Funder(s)
  • Royal Marsden NHS Foundation Trust
Other Study ID Numbers
ICR-CTSU/2009/10020
Sponsor(s)
Institute of Cancer Research, United Kingdom
Key Dates

Recruitment Start Date

Dec 2009

Recruitment End Date

Jun 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

13 Apr 2011

Date updated in source

18 May 2012