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

Brief Title

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

Official Title

A Phase II Trial of Nilotinib in the Treatment of Patients With c-KIT Mutated Advanced Acral and Mucosal Melanoma

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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Proportion of participants with the c-KIT mutation who remain progression free at 6 months.

Secondary Outcome

 toxicity of treatment

Condition

Mucosal Lentiginous Melanoma

Intervention

nilotinib

Study Arms / Comparison Groups

 nilotinib
Description:  nilotinib 400mgs oral tablets

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

29

Start Date

December 2009

Completion Date

December 12, 2016

Primary Completion Date

December 12, 2016

Eligibility 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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James Larkin, MA BM BCh MRCP PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01395121

Organization ID

ICR-CTSU/2009/10020

Secondary IDs

2009-012945-49

Responsible Party

Sponsor

Study Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

 Royal Marsden NHS Foundation Trust

Study Sponsor

James Larkin, MA BM BCh MRCP PhD, Principal Investigator, Royal Marsden NHS Foundation


Verification Date

June 2017