A Phase II Trial of Nilotinib in the Treatment of Patients with c-KIT Mutated Advanced Acral and Mucosal Melanoma (NICAM) - Nilotinib in the Treatment of c-KIT Mutated Melanoma (NICAM)

Phase 1

• Conditions: MedDRA version: 10 Level: LLT Classification code 10025654 Term: Malignant melanoma of sites other than skin; MedDRA version: 10 Level: LLT Classification code 10000583 Term: Acral lentiginous melanoma; c-KIT mutated advanced acral or mucosal melanoma

• Registration Number: EUCTR2009-012945-49-GB
• Lead Sponsor: Royal Marsden Hosptial Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-17
• Study Completion: 2016-12-12
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 29

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. Unresectable locally advanced or metastatic disease
3. The presence of one or more clinically or radiologically measurable lesions at least 10mm in size
4. ECOG performance status 0, 1 or 2
5. Life expectancy greater than 12 weeks
6. At least 28 days since major surgery and 7 days since skin/tumour biopsy
7. The capacity to understand the patient information sheet and the ability to provide written informed consent
8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
9. Age 18 or greater
10. Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (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 sterilization) 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) =2.5 x upper limit of normal (ULN), total serum bilirubin =1.5 x ULN
12. Serum creatinine =1.5 x ULN
13. Haemoglobin =9.0 g/dL, absolute neutrophil count =1.5 x 109/L, platelets =100 x 109/L
14. Prothrombin time (PT) =1.5 x ULN

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 pregnancy within 6 months after the last treatment
3. Men who plan to father a child within 6 months of the last treatment
4. Use of any investigational drug within 30 days prior to screening
5. Significant cardiac disease including patients who have or who are at significant risk of developing prolongation of QTc
6. Severe and/or uncontrolled medical disease
7. Known chronic liver disease
8. Known HIV infection
9. Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy in the 4 weeks prior to study entry
10. Prior exposure to a tyrosine kinase inhibitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary end point(s): The primary endpoint is the proportion of participants progression free at 6 months.<br> ;Main Objective: To evaluate the safety and effectiveness of the drug nilotinib in the treatment of acral and mucosal melanomas which have mutations in a cell surface protein known as c-KIT.;Secondary Objective: To investigate the biology of response and resistance to nilotinib treatment.