Condition category
Cancer
Date applied
15/05/2009
Date assigned
10/07/2009
Last edited
06/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr James Larkin

ORCID ID

Contact details

The Royal Marsden Hospital NHS Foundation Trust
Fulham Road
London
SW3 6JJ
United Kingdom
+44 (0)20 7808 2132
james.larkin@rmh.nhs.uk

Additional identifiers

EudraCT number

2009-012945-49

ClinicalTrials.gov number

NCT01395121

Protocol/serial number

ICR-CTSU/2009/10020

Study information

Scientific title

A phase II trial of nilotinib in the treatment of c-KIT mutated advanced acral and mucosal melanoma (NICAM)

Acronym

NICAM

Study hypothesis

The NICAM trial will test the hypothesis that the c-KIT tyrosine kinase inhibitor nilotinib is active in c-KIT mutant advanced acral and mucosal melanoma.

Ethics approval

Oxfordshire C, 20/11/2009, ref: 09/H0606/103

Study design

Single-arm phase II clinical trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced acral or mucosal melanoma

Intervention

Nilotinib 400 mg twice daily (bid). Treatment will continue for as long as the patient receives clinical benefit.

Intervention type

Drug

Phase

Phase II

Drug names

Nilotinib

Primary outcome measures

Proportion of patients progression free at 6 months

Secondary outcome measures

1. Response rate at 12 weeks
2. Overall survival at 6 months from treatment start
3. Toxicity of treatment at 6 months from treatment start
4. Correlation between c-KIT mutation, gene amplification, overexpression and response to treatment and survival at 6 months from treatment start
5. Changes in circulating tumour cells at 6 months from treatment start

Overall trial start date

01/08/2009

Overall trial end date

25/11/2015

Reason abandoned

Eligibility

Participant 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 10 mm in size
4. Eastern Cooperative Oncology Group (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. Aged 18 years or greater, either sex
10. Women must be post-menopausal (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 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) less than or equal to 2.5 x upper limit of normal (ULN), total serum bilirubin less than or equal to 1.5 x ULN
12. Serum creatinine less than or equal to 1.5 x ULN
13. Haemoglobin greater than or equal to 9.0 g/dL, absolute neutrophil count greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 100 x 10^9/L
14. Prothrombin time (PT) less than or equal to 1.5 x ULN

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24 (Patients are first registered and progress to study entry if they remain eligible. Approximately 120 patients will be required to register to enable the target of 24 at study entry to be reached).

Participant exclusion criteria

1. Intracranial disease, unless there has been radiological evidence of stable intracranial disease greater than 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 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 human immunodeficiency virus (HIV) infection
9. Previous radiotherapy to 25% or more of the bone marrow
10. Radiation therapy in the 4 weeks prior to study entry
11. Prior exposure to a tyrosine kinase inhibitor

Recruitment start date

15/12/2009

Recruitment end date

04/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal Marsden Hospital NHS Foundation Trust
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

The Royal Marsden NHS Foundation Trust/The Institute of Cancer Research (ICR) (UK)

Sponsor details

Clinical R&D Office
West Wing
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 (0)20 8661 3909
research.development@rmh.nhs.uk

Sponsor type

Government

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C28772/A11401)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Novartis (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Results and Publications

Publication and dissemination plan

A manuscript will be submitted to a quality, peer reviewed, journal.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 06/04/2016 the overall trial end date was changed from 31/12/2011 to 25/11/2015.