Condition category
Cancer
Date applied
18/01/2008
Date assigned
13/02/2008
Last edited
29/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Ernist Marshall

ORCID ID

Contact details

Clatterbridge Centre for Oncology NHS Foundation Trust
Clatterbrige Road
Bebington
Wirral
Merseyside
CH63 4JY
United Kingdom
+44 (0)151 482 7801
emarshall@nhs.net

Additional identifiers

EudraCT number

2007-006216-39

ClinicalTrials.gov number

Protocol/serial number

CCO2007/18

Study information

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

Acronym

ITEM

Study hypothesis

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

Added 06/02/2009: Bolton Research Ethics Committee gave approval on the 30th June 2008 (ref: 08/H1010/21)

Study design

Single arm, multicentre, two stage, phase II study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

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

Phase

Phase II

Drug names

Imatinib

Primary outcome measures

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 trial start date

01/04/2008

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

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

Participant 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

Recruitment start date

01/04/2008

Recruitment end date

01/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clatterbridge Centre for Oncology NHS Foundation Trust
Merseyside
CH63 4JY
United Kingdom

Sponsor information

Organisation

Clatterbridge Centre for Oncology NHS Foundation Trust (UK)

Sponsor details

Clatterbridge Road
Bebington
Wirral
Merseyside
CH63 4JY
United Kingdom
+44 (0)151 334 1155
Gill.Sims@ccotrust.nhs.uk

Sponsor type

Government

Website

http://www.ccotrust.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C1810/A9396)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/02/2016: No publications found, verifying study status with principal investigator.