ITEM - a phase II study of imatinib in the treatment of patients with metastatic uveal melanoma

ISRCTN	ISRCTN91548930
DOI	https://doi.org/10.1186/ISRCTN91548930
EudraCT/CTIS number	2007-006216-39
Secondary identifying numbers	CCO2007/18

Submission date: 18/01/2008
Registration date: 13/02/2008
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-imatinib-for-melanoma-of-the-eye-that-has-spread

Study website

Contact information

Dr Ernist Marshall
Scientific

Clatterbridge Centre for Oncology NHS Foundation Trust
Clatterbrige Road
Bebington, Wirral
Merseyside
CH63 4JY
United Kingdom

Phone	+44 (0)151 482 7801
Email	emarshall@nhs.net

Study information

Study design	Single arm, multicentre, two stage, phase II study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A single arm, multi-centre, two stage, phase II study of imatinib in good performance status patients with c-kit positive metastatic melanoma
Study acronym	ITEM
Study objectives	The aim of this study is to determine the efficacy of imatinib in patients with metastatic uveal melanoma based upon standard radiological and positron emission tomography (PET)/computed tomography (CT) response.
Ethics approval(s)	Added 06/02/2009: Bolton Research Ethics Committee gave approval on the 30th June 2008 (ref: 08/H1010/21)
Health condition(s) or problem(s) studied	Metastatic eye melanoma
Intervention	This is a single arm phase II study. Stored tissue of primary ocular tumour and/or metastatic biopsies will be collected at baseline to determine eligibility and will be available for associated translational research. All patients will be asked to consent for collection of serum samples at baseline. All patients will receive imatinib 400 mg to be taken by mouth once a day. Patients will be followed up every 28 days for toxicity and will remain on study drug until disease progression, death, unacceptable toxicity or patient choice. CT will be at baseline and at weeks 6 and 12 with 8 weekly scans thereafter. PET will be in selected centres at baseline, week 6 and 12. Patients will be followed until death for overall survival.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Imatinib
Primary outcome measure	Progression-free survival at 3 months.
Secondary outcome measures	1. Objective response rate, according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria, assessed every 8 weeks 2. Overall survival (OS) assessed at date of first treatment to date of death and safety and toxicity, assessed every 28 days 3. Biomarker correlation with outcome measures 4. PET response (European Organisation for Research and Treatment of Cancer [EORTC] guidelines, Young, 1999)
Overall study start date	01/04/2008
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	The trial will adopt a two-stage Gehan design enrolling 14 patients in the first stage, reaching a maximum of 25 patients
Total final enrolment	25
Key inclusion criteria	1. Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (c-kit positive on immunohistochemistry [IHC]) 2. Any prior therapy for advanced disease excluding agents targeting c-kit 3. Life expectancy greater than 12 weeks 4. World Health Organization (WHO) performance status 0, 1 or 2 5. Presence of one or more measurable lesions 6. Age greater than 18 years, either sex 7. Adequate haematological, renal and liver function 8. Written informed consent provided by the patient
Key exclusion criteria	1. C-kit negative uveal melanoma 2. Any previous investigational agent within the last 12 weeks 3. Known leptomeningeal or brain metastases 4. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial 5. Any medical or psychiatric condition which would influence the ability to provide informed consent 6. Pregnant or lactating women
Date of first enrolment	01/04/2008
Date of final enrolment	01/04/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clatterbridge Centre for Oncology NHS Foundation Trust

Merseyside
CH63 4JY
United Kingdom

Sponsor information

Clatterbridge Centre for Oncology NHS Foundation Trust (UK)
Hospital/treatment centre

Clatterbridge Road
Bebington, Wirral
Merseyside
CH63 4JY
England
United Kingdom

Phone	+44 (0)151 334 1155
Email	Gill.Sims@ccotrust.nhs.uk
Website	http://www.ccotrust.nhs.uk/
"ROR"	https://ror.org/05gcq4j10

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C1810/A9396)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	29/03/2018: Results presented at ASCO Annual Meeting 2012 (https://meetinglibrary.asco.org/record/70522/abstract)
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
29/03/2018: Conference proceedings added to publication and dissemination plan.
29/02/2016: No publications found, verifying study status with principal investigator.