First line treatment of metastatic bowel cancer with S95005 & Avastin
Research type
Research Study
Full title
An open-label, randomised, phase 2 study comparing S 95005 plus bevacizumab to capecitabine plus bevacizumab in patients with previously untreated metastatic colorectal cancer who are non-eligible for intensive therapy
IRAS ID
196447
Contact name
Mark Peter Saunders
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier
Eudract number
2015-004544-18
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
This study is investigating S 95005 (TAS-102) in combination with bevacizumab in patients with bowel cancer that is not operable (unresectable) and has spread throughout the body (metastatic colorectal cancer mCRC).
S95005 has received marketing approval in US and Japan (EMA decision is expected soon).
S95005 is taken orally and inhibits tumour growth by interferring with cell growth. Bevacizuamb is given by intravenous infusion and inhibits growth of blood vessels which support tumour growth.
The main aim of the study will analysis the effectiveness of S95005 in combination with bevacizumab in preventing tumour growth in mCRC patients who have not received any treatment for metastatic disease yet. Main secondary aims will analyse safety, tolerability, duration of response and overall survial and 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 weeks 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 12 weeks by asking the patients to complete a questionnaire.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0169
Date of REC Opinion
22 Mar 2016
REC opinion
Favourable Opinion