The MAGENTA trial: The molecular biology of metastatic cancer

ISRCTN ISRCTN23406143
DOI https://doi.org/10.1186/ISRCTN23406143
Secondary identifying numbers 17675
Submission date
23/12/2015
Registration date
23/12/2015
Last edited
14/09/2016
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-study-to-find-why-cancer-treatment-stops-working-magenta

Contact information

Miss Mohana Suppiah
Public

Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Study information

Study designNon-randomised clinical laboratory study
Primary study designObservational
Secondary study design
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMAGENTA: Metabonomic-genomic signature correlates of clinical resistance in metastatic cancer treated with anti-EGFR therapy
Study acronymMAGENTA
Study objectivesThe aim of this study is to investigate the clinical resistance in metastatic cancer treated with anti-EGFR therapy.
Ethics approval(s)London - Queen Square Research Ethics Committee, 02/12/2014, ref: 14/LO/1650
Health condition(s) or problem(s) studiedTopic: Cancer; Subtopic: Colorectal Cancer, Head and Neck Cancer, Lung Cancer; Disease: Colon, Head and Neck, Lung (small cell), Lung (non-small cell), Skin
InterventionPatients 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 typeOther
Primary outcome measureThe identification and validation of potential biomarkers in the form of specific differences in metastatis
Secondary outcome measuresNot provided at time of registration
Overall study start date02/12/2014
Completion date06/03/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 70; UK Sample Size: 70
Key inclusion criteria1. ­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
Key exclusion criteria1. 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
Date of first enrolment02/12/2014
Date of final enrolment06/03/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor information

Imperial College London
University/education

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

ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Research organisation

Experimental Cancer Medicine Centre Network

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

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