Phase I Study of E7050 in Patients with Advanced Solid Tumours
Research type
Research Study
Full title
A Phase I Dose-Finding Study of E7050 Administered Orally to Patients with Advanced Solid Tumours
IRAS ID
6248
Contact name
R Molife
Sponsor organisation
Eisai Limited
Eudract number
2008-002189-76
Clinicaltrials.gov Identifier
Research summary
c-Met, is a protein that, when in excess amounts, can drive the growth of many cancers including those of the stomach, lung, breast, prostate and kidney. Another protein, vascular endothelial growth factor (VEGF) and its receptor VEGFR, are also implicated in the growth of cancers, by promoting the growth of blood vessels within cancers allowing nutrients to be transported to and waste transported from growing cancers. E7050 is a new compound that blocks the action of c-Met and VEGFR and may therefore slow the growth of several cancer types. The main purpose of this study is to identify the highest safest dose of E7050, which could then be further investigated in future clinical trials. Other aims are to define the safety, effectiveness and pharmacokinetics (how E7050 is absorbed, broken down and excreted by the human body) of E7050. Groups (cohorts) of 3 to 6 patients will be recruited to escalating dose levels of E7050, until this dose is defined. The increase in doses will depend on the side effects seen in the previous group of patients. The study will take place at 2 hospitals in the UK and is funded by the pharmaceutical company, Eisai Limited.While on treatment, patients will attend the hospital for 2 overnight stays at the beginning of the 1st 2 cycles. They will then attend for study assessments to evaluate PK and safety on a weekly basis. Computed tomography (CT) or magnetic resonant imaging (MRI) scans to determine the effect of E7050 on the growth of the patient's cancer will be performed every 8 weeks. Study treatment can continue until evidence of progressive disease, unacceptable side effects, or withdrawal of patient's consent. Within 30 days after the end of study treatment, the patient will be asked to return for a final study visit.
REC name
London - City & East Research Ethics Committee
REC reference
08/H0703/141
Date of REC Opinion
4 Feb 2009
REC opinion
Further Information Favourable Opinion