Phase I trial of RO5126766, a dual RAF/MEK inhibitor
Research type
Research Study
Full title
A Phase I trial of RO5126766 (a dual RAF/MEK inhibitor) exploring intermittent, oral dosing regimens in patients with solid tumours or multiple myeloma
IRAS ID
102403
Contact name
Udai Banerji
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2012-001040-22
ISRCTN Number
n/a
Research summary
This is a phase 1b study to further evaluate the safety and toxicity profile of RO5126766 a novel anti-cancer agent. This study consists of two parts: In Part I: RO5126766 will be given orally as a once a day dose of 4mg either twice per week (Monday and Thursday) or three times per week (Monday, Wednesday and Friday) over a 28 day period that will constitute a cycle. Patients with refractory solid tumours will be asked to participate in order to determine the optimum schedule to be taken forward to Part II of the study. Pharmacokinetic analysis(what the body does to the drug i.e. how much and how long the drug remains in the body and how it is broken down and removed from the body)will be performed and pharmacodynamic (how the drug affects the body i.e. what changes it makes to both normal and tumour cells) markers will be measured in the blood (Part I only). In Part II: 20 patients with either solid tumours or multiple myeloma with documented KRAS, NRAS or BRAF genetic mutations will be enrolled to evaluate any possible clinical activity i.e. does the tumour shrink?. Optional paired tumour biopsies will be collected for analysis of biological markers that are related to how RO5126766 works as an anti cancer drug. There will also be optional imaging studies (diffusion-weighted MRI and 18F-choline PET) that will be performed in Part II to have a better picture of the effect of RO5126766 on the tumour.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
12/LO/1407
Date of REC Opinion
12 Nov 2012
REC opinion
Further Information Favourable Opinion