A Phase 1 dose escalation study of LEQ 506 in advanced solid tumours
Research type
Research Study
Full title
A Phase 1 multi centre open label dose escalation study of LEQ 506 an oral smoothened inhibitor in patients with advanced solid tumours
IRAS ID
54817
Contact name
Mark Middleton
Sponsor organisation
Novartis Pharma Services
Eudract number
2009-017969-30
Clinicaltrials.gov Identifier
Research summary
This is a Phase I, first-in-human study which means the drug has shown promise in animal testing and this is the first clinical study in humans. The aim of this study is to find the highest dose of the study drug, LEQ506 that can be given safely to humans and to determine the immediate and long term side effects of the treatment. The new drug, LEQ506 acts by inhibiting a specific protein from sending growth signals to the cancer cells. This drug has been shown to prevent the growth of tumours in animals. LEQ506 targets a protein that has an important role in the development and growth of several different cancers such as basal cell carcinoma (a skin cancer), medulloblastoma (a brain cancer), pancreatic cancer, lung cancer, prostate cancer and stomach cancer. LEQ506 is being studied in adult patients with advanced solid tumours which have progressed despite the standard treatment or for which no curative treatment exists. This trial is an open label study which means that everyone participating will receive LEQ506. LEQ506 is an oral capsule that patients will take every day on a 21 day cycle. The trial is a dose-escalation study which means the initial dose given to patients will be low and will only be increased when it has been assessed to be safe. Once the maximal tolerated dose is reached the expansion part of the study will be opened to recruitment. The expansion part of the study will treat patients with tumours that are characterised by the Hedgehog pathway activation such as metastatic or locally advanced basal cell carcinoma and patients with recurrent or refractory medullablastoma. Patients will be treated at a single dose level to further assess the safety and tolerability of LEQ506.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
10/H0605/44
Date of REC Opinion
20 Sep 2010
REC opinion
Further Information Favourable Opinion