A Phase I/II Study of WX-554 in Solid Tumours
Research type
Research Study
Full title
A Phase I/II, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the MEK inhibitor WX-554 in patients with solid tumours
IRAS ID
94784
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
WILEX AG
Eudract number
2011-003408-19
ISRCTN Number
N/A
Research summary
The purpose of this study is to test the safety of WX-554 (a MEK inhibitor) and see what effects it has on patients with solid tumours. Analysis of this drug in the lab suggests that it could have an anti-cancer effect. The study has a Part 1 and a Part 2. Part 1 (escalation phase) of the study will investigate increasing dose levels of study drug with the aim of identifying the Optimal Biological Dose (OBD) or the Maximum Tolerated Dose (MTD), whichever is identified first. The OBD is the dose which shows the most inhibition of the cell pathway (the target). The MTD is the highest safe dose for a person receiving study drug. The OBD/MTD dose level(s) identified in Part 1 will be taken into Part 2 (expansion phase) and further evaluated. Adjustments to the dose level and frequency of drug administration may be investigated in Part 2 of the study. If the OBD is taken into Part 2, further dose levels may continue to be investigated in Part 1, thus Part 1 and Part 2 of the study may run in parallel. The length of time in this study depends on how well patients tolerate the study drug. Patients can have as many cycles of 3 weeks as they can tolerate without unacceptable side effects. There will be a screening period of up to 2 weeks prior to treatment and follow up at one week and then at 30 days after last study drug administration.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
11/NE/0376
Date of REC Opinion
25 Jan 2012
REC opinion
Further Information Favourable Opinion