Condition category
Cancer
Date applied
23/12/2015
Date assigned
23/12/2015
Last edited
14/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Miss Mohana Suppiah

ORCID ID

Contact details

Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17675

Study information

Scientific title

MAGENTA: Metabonomic-genomic signature correlates of clinical resistance in metastatic cancer treated with anti-EGFR therapy

Acronym

MAGENTA

Study hypothesis

The aim of this study is to investigate the clinical resistance in metastatic cancer treated with anti-EGFR therapy.

Ethics approval

London - Queen Square Research Ethics Committee, 02/12/2014, ref: 14/LO/1650

Study design

Non-randomised clinical laboratory study

Primary study design

Observational

Secondary study design

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Cancer; Subtopic: Colorectal Cancer, Head and Neck Cancer, Lung Cancer; Disease: Colon, Head and Neck, Lung (small cell), Lung (non-small cell), Skin

Intervention

Patients presenting to the Cancer Centre will receive an information sheet broadly describing research into the molecular biology of metastatic cancer. It will be made clear to patients that clinical information will be coded and linked to the molecular information. Patients with mCRC undergoing treatment with EGFR inhibitors will be the test sample population with an initial aim of 30-50 patients. There will also be a control group of non-EGFR treated patients (RAS- mutant or otherwise) of a minimum of 20 patients. Archival tumour tissue will be collected at baseline with an optional tissue biopsy at disease progression. 2-3 weekly collections of blood and urine will take place. A second control group will consist of 10 patients with any metastatic cancer receiving EGFR inhibitor therapy.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The identification and validation of potential biomarkers in the form of specific differences in metastatis

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/12/2014

Overall trial end date

06/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. ­Histologically or cytologically confirmed colorectal cancer; or
2. Histologically or cytological confirmed lung, squamous cell, or head and neck cancers (only 10 patients required)
3. To commence EGFR inhibitor monotherapy or in combination with cytotoxic chemotherapy for the test populationb or to commence any other cytotoxic chemotherapy with or without an angiogenesis inhibitor for the control population
5. Confirmation of tumour KRAS / NRAS status as KRAS / NRAS WT in the test population, with mutation assessments in BRAF, NRAS, PIK3CA exon20 , PTEN if assessable, by means of mutation or relevant analysis performed on representative samples of diagnostic tumour tissue (the same profile will be done in controls with no pre­requisite mutation specified entry criteria)
­6. Ability to provide informed consent
­7. 18 years of age or older
8. ECOG performance status of = 2
­9. Life expectancy of at least 12 weeks
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 70; UK Sample Size: 70

Participant exclusion criteria

1. Brain metastases that are either untreated, symptomatic, or which have not been stable for at least one month after treatment
2. Severe restrictive lung disease or radiological pulmonary findings of “interstitial lung disease” on the CT scan image available prior to commencement of the treatment which, in the opinion of the investigator, represents significant pathology
3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow­up schedule, including alcohol dependence or drug abuse
4. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow­up schedule, including alcohol dependence or drug abuse
5. Known human immunodeficiency virus (HIV) infection
6. Presence of grade =2 peripheral neuropathy.
7. Severe or uncontrolled cardiovascular disease (e.g. acute coronary syndromes, cardiac failure NYHA III or IV, clinically relevant myopathy, history of myocardial infarction within the last 12 months, significant arrhythmias)
8. Any co­-morbididty that is likely to lead with interference with study treatment

Recruitment start date

02/12/2014

Recruitment end date

06/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Trial participating centre

Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Experimental Cancer Medicine Centre Network

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

14/09/2016: Cancer Help UK lay summary link added.