Eribulin in combination with capecitabine
Research type
Research Study
Full title
A Phase 1b/2, Multicenter, Randomized, Open-label, Dose-escalation and Confirmation Study of Eribulin in Combination with Capecitabine
IRAS ID
30678
Contact name
Thomas Ronald Jeffry Evans
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2009-011217-24
Clinicaltrials.gov Identifier
01323530
Research summary
Eribulin is a new compound that's being investigated for its anti-cancer activity. Capecitabine is an anti-cancer drug that has been proven to be effective in the treatment of several different types of cancer. It is hoped that when eribulin is given together with capecitabine the anti-cancer effect will be enhanced with tolerable side-effects. The study is funded by the pharmaceutical company Eisai, who have developed eribulin. The study is designed in two parts and will assess two different ways of giving the drugs together.The first part, called dose-escalation or phase 1b, is to find the maximum dose of the two drugs that can be given together safely. Patients with cancer that has spread or returned and worsened after previous treatment will be invited to participate in this part of the study. This part will take place in 3 hospitals in the UK. The second part, dose-confirmation or phase 2, will further investigate the combination using the safe doses found in phase 1b and find out how effective the treatment is for female patients with breast cancer that has spread or returned after previous treatment. This part will take place in 3 hospitals in the UK and further hospitals in Europe.During the study patients will be asked to attend clinics weekly for infusions of eribulin, to be given capecitabine tablets, and safety tests. Safety tests include physical examinations, blood and urine sampling, and monitoring the activity of the heart. Scans will be performed every 6 weeks to determine the effect of treatment on the patient??s disease. Bone scans may be performed every 18 weeks if necessary. Pharmacokinetic blood samples to define how the drugs are absorbed, broken down and excreted from the body will be taken.Study treatment can continue until disease worsening, unacceptable side-effects, patient or investigator decision.
REC name
West of Scotland REC 1
REC reference
09/S0703/110
Date of REC Opinion
3 Dec 2009
REC opinion
Further Information Favourable Opinion