Phase 2 open label study in advanced colorectal cancer
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Study of DS-8201A in Subjects with HER2-Expressing Advanced Colorectal Cancer
IRAS ID
238485
Contact name
Ian Chau
Contact email
Sponsor organisation
Daiichi Sankyo Inc.
Eudract number
2017-003466-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Patients in this study have advanced colorectal cancer with a higher than normal level of a protein called HER2. This protein helps the cancer cells to grow. Currently there are no approved therapies which target HER2 in colorectal cancer, therefore this study will investigate the safety of the study drug DS-8201a in this group of patients and see how well the participants tolerate the drug. There will be 3 groups of participants:
Group A - approximately 50 participants will enter this group; data will be reviewed after at least 20 participants complete the tumour assessments at 12 weeks and the benefits and risks will be observed. The next two groups will be opened depending upon these results.
Group B - approximately 20 participants with a certain type of HER2 protein (low levels) will enter this group.
Group C - approximately 20 participants with a different type of HER2 protein (higher levels) from Group B will enter this group.
The study drug is expected to inhibit tumour growth and in previous trials it appeared to be well-tolerated. To be eligible for the study participants may need a tumour biopsy unless a stored sample of tumour was obtained after their most recent cancer therapy. Treatment will be in cycles of 21 days and participants will remain on study medication for as long as they maintain benefit from the treatment. After the end of treatment, survival data will be collected from participants every 3 months.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0720
Date of REC Opinion
26 Jun 2018
REC opinion
Further Information Favourable Opinion