A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread

NCT01395121 | Completed Phase 2 DMC

• 6 other identifiers: ICR-CTSU/2009/100202009-012945-49Oxfordshire C 09/H0606/103CRUK/09/028CTA 15983/0226/001ISRCTN 39058880
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mucosal Lentiginous Melanoma; Acral Lentiginous Malignant Melanoma

Keywords

c-KIT mutation; advanced disease; tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with the c-KIT mutation who remain progression free at 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.

  6 months

Secondary Outcomes (3)

• 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)

Study Arms (1)

nilotinib

EXPERIMENTAL

nilotinib 400mgs oral tablets

Drug: nilotinib

Interventions

nilotinib DRUG

nilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment

Also known as: Tasigna

nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The capacity to understand the patient information sheet and ability to provide written informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
• 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
• Serum alanine transaminase (ALT) or serum aspartate aminotransferase ≤2.5 x upper limit of normal (ULN) and total serum bilirubin ≤1.5 x ULN
• Serum creatinine ≤1.5 x ULN
• Serum lipase and amylase \<1.5 x ULN
• Haemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.5 x 109/L, platelets ≥100 x 109/L
• Prothrombin time (PT) ≤1.5 x ULN

You may not qualify if:

• 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
• Severe and/or uncontrolled medical disease
• Known chronic liver disease
• Past medical history of chronic pancreatitis
• Known HIV infection
• Previous radiotherapy to 25% or more of the bone marrow
• Radiation therapy in the 4 weeks prior to study entry
• Prior exposure to a tyrosine kinase inhibitor
• Known lactose intolerance

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Interventions

nilotinib

Study Officials

• James Larkin, MA BM BCh MRCP PhD

  Royal Marsden NHS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: July 15, 2011
• Study Start: December 1, 2009
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

GB (1)