Study of fruquintinib in patients with metastatic colorectal cancer
Research type
Research Study
Full title
A global, randomized, placebo-controlled phase 3 study of fruquintinib in patients with refractory metastatic colorectal cancer
IRAS ID
282796
Contact name
Leslie Samuel
Contact email
Sponsor organisation
Hutchison MediPharma Limited
Eudract number
2020-000158-88
Clinicaltrials.gov Identifier
131038, IND Number
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Colorectal cancer (CRC) is the second most common cancer in both men and women, with more than 20,000 cases per year in the UK. CRC is a cancer that starts in the colon or the rectum. Metastatic CRC (mCRC) is when the cancer has spread to other parts of the body. There is currently no standard of care for these patients who have progressed on approved standard-of-treatments.
Fruquintinib (HMPL-013) is a new drug which blocks a pathway (vascular endothelial cell growth factor receptor (VEGFR) signalling pathway) that some cancers use to grow and divide.
The purpose of this study is to find out whether HMPL-013 plus best supportive care is safe and is better than placebo (dummy drug with no active medicine inside) plus best supportive care in patients with metastatic CRC that have not responded to previous treatment.
Patients will be randomly assigned to receive either HMPL-013 plus best supportive or placebo plus best supportive care. Neither the patient nor the doctor will know which treatment is being given. Patients will take HMPL-013 or placebo capsules by mouth once daily for 3 weeks followed by 1 week off (4-week cycle) until discontinuation.
Around 522 participants will be enrolled in this study at approx. 110 hospitals worldwide.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0160
Date of REC Opinion
6 Jul 2020
REC opinion
Favourable Opinion