Mucosal Lentiginous MelanomaPhase 2NICAMNCT01395121
A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread
A Phase 2 study testing nilotinib in people with Mucosal Lentiginous Melanoma and Acral Lentiginous Malignant Melanoma, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
- What is being tested?
- nilotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to 12 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
- Able to swallow and retain oral medication.
Who cannot join
- 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)
Show all 16Show fewer
- 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
- Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn's disease or ulcerative colitis).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: A Phase II Trial of Nilotinib in the Treatment of Patients With c-KIT Mutated Advanced Acral and Mucosal Melanoma
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.
Read the 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.
- Being tested
- nilotinib
- Keywords
- c-KIT mutation, advanced disease, tyrosine kinase inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nilotinibDrug
Also called Tasigna
nilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment
| Study group | Role | What they receive |
|---|---|---|
| nilotinib | Experimental | nilotinib 400mgs oral tablets Receives: Drug: nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
toxicity of treatment
Treatment related toxicity will be assessed at each clinic visit approximately every 4 weeks whilst the patient continues on study treatment. Study treatment will continue until the patient relapses or is withdrawn from study therapy (on average estimated to be between 4 and 52 weeks).
Measured: evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks)
response at 12 weeks
Lesions must be measured and or evaluated at 12 weeks in accordance with the Response evaluation criteria in solid tumours (RECIST)
Measured: tumours measured at 12 weeks from start of treatment
overall survival
Measured: Expected to be 6 - 12 months (Measured from commencement of treatment until time of death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startDec 2009
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal Lentiginous MelanomaStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- James Larkin, MA BM BCh MRCP PhD, Principal investigator, Royal Marsden NHS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395121
- Sponsor's protocol ID
- ICR-CTSU/2009/10020
- Other IDs
- 2009-012945-49, Oxfordshire C 09/H0606/103, CRUK/09/028, CTA 15983/0226/001, ISRCTN 39058880, 2009
- Acronym
- NICAM
- Status last verified
- Jun 2017
- First submitted
- 13 Apr 2011
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Nilotinib in the Treatment of Patients With c-KIT Mutated Advanced Acral and Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT01395121
- Acronym / sponsor ID
- NICAM / ICR-CTSU/2009/10020
- Keywords
- c-KIT mutation, advanced disease, tyrosine kinase inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- Dec 2009 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nilotinib | Experimental | Drug: nilotinibnilotinib 400mgs oral tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nilotinibAlso: Tasignanilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment | Drug | nilotinib |
Primary outcome
Proportion of participants with the c-KIT mutation who remain progression free at 6 months.
Time frame: 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.
3 secondary outcomes
toxicity of treatment
Time frame: evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks)
response at 12 weeks
Time frame: tumours measured at 12 weeks from start of treatment
overall survival
Time frame: Expected to be 6 - 12 months (Measured from commencement of treatment until time of death)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
Related trials for Mucosal Lentiginous Melanoma
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
Not yet recruitingPhase 2
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
RecruitingPhase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Advanced Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
Dinaciclib in Treating Patients With Stage IV Melanoma
Acral Lentiginous Melanoma, Cutaneous Nodular Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Larkin, MA BM BCh MRCP PhD principal investigator
Royal Marsden NHS Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nilotinib in people with Mucosal Lentiginous Melanoma and Acral Lentiginous Malignant Melanoma, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with the c-KIT mutation who remain progression free at 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.