Plain English Summary
Trial website
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
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