CL3-95005-006 SOLSTICE
Research type
Research Study
Full title
An open-label, randomised, phase III Study cOmparing trifLuridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in firST-line treatment of patients with metastatIC colorectal cancer who are not candidatE for intensive therapy (SOLSTICE study)
IRAS ID
239606
Contact name
Mark Saunders
Contact email
Sponsor organisation
Servier Research and Development Ltd UK
Eudract number
2017-004059-22
Duration of Study in the UK
3 years, 10 months, 1 days
Research summary
This study is investigating S95005 (trifluridine/tipiracil) in combination with bevacizumab, versus capecitabine in combination with bevacizumab. This will be looked at in patients with bowel cancer that is not operable (unresectable) and not suitable for intensive therapy, and that has spread throughout the body (metastatic colorectal cancer, mCRC).
The study drug, S95005, is a new anticancer drug that has been approved in Japan, United States and in the European Union under the trade name of Lonsurf.
The main aim of the study is to determine if S95005 in combination with bevacizumab is better than capecitabine with bevacizumab for progression free survival in mCRC patients who have not received any treatment for metastatic disease yet and are not suitable for intensive chemotherapy.
The main secondary aims will analyse safety, tolerability, duration of response and overall survival. Exploratory aims will try to evaluate how the tumour responds to the treatment by analysis of blood and tumour tissue samples.
There are two arms: patients will be randomly assigned to one arm, either S95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm).
Eligible patients will receive treatment for either 3 or 4 week cycles (depending on the treatment combination). They will attend the hospital for their research visits. Patients will receive the treatment for as long as they tolerate it and disease does not worsen. An assessment of the tumour size will be made every 8 weeks by an appropriate imaging technique. Quality of life will be assessed every 6 weeks by asking the patients to complete a questionnaire.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0099
Date of REC Opinion
1 Jun 2018
REC opinion
Further Information Favourable Opinion