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Prospective Translational Study Investigating Molecular Predictors of Resistance and Response to Regorafenib Monotherapy

NCT03010722 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2021-05-03

No results posted yet for this study

Summary

This is a single centre prospective biological translational research study involving the collection of tumour tissue, blood samples and clinical data from patients being treated with regorafenib for metastatic Colorectal Cancer (mCRC) at the Royal Marsden Hospital. Patients will be eligible for the study if they have a histological diagnosis of CRC, are refractory to standard available therapies with palliative intent for mCRC, have received prior treatment with at least one anti-VEGF antibody and chemotherapy drugs including fluorouracil (5FU) or capecitabine, oxaliplatin and irinotecan, and patients have RAS mutant tumours.

Conditions

Interventions

DRUG

Regorafenib

Patients meeting all of the inclusion criteria and none of the exclusion criteria will receive regorafenib 160 mg orally (po) od for 3 weeks of every 4-week cycle. Each cycle will comprise 3 weeks of treatment followed by 1 week without treatment, hereafter described as "3 weeks on/1 week off". Each 160-mg dose will include four regorafenib 40-mg tablets.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-01-31
Completion
2017-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03010722 on ClinicalTrials.gov