AZD5363 Formulation Comparison, Effect of Food, Safety & Tolerability
Research type
Research Study
Full title
A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients with Advanced Solid Malignancies (OAK)
IRAS ID
138180
Contact name
Udai Banerji
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-002425-37
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
AstraZeneca is conducting a research study with AZD5363, a new anticancer agent, in patients with advanced cancers.
Laboratory studies have shown that AZD5363 helps to reduce the growth of some cancer cells, therefore patients may benefit from participating in the study, but there is no guarantee.
This study comprises two parts (A and B). Part A is designed to compare the amount of drug exposure of a new tablet formulation with that of the capsule formulation. Part B is designed to investigate the effect of food has on the drug exposure of a new tablet formulation.
The study will assess the safety and tolerability of AZD5363, the tumour response and how the body handles the study treatments (e.g. absorption and removal of AZD5363). The study will also measure various biomarkers(substances that help to measure or predict progress of disease or the effect of treatment) and will look at how genes (the building blocks of cells) affect the response to the drug.
Patients will be recruited from 3 clinical centres in Europe. After giving consent to take part, patients will attend frequent hospital visits throughout the study. At each visit, assessments will be made to check the patient’s health and see how the drug is working. Patients may remain on drug for as long as they are receiving benefit and are not experiencing unacceptable side effects.REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/1827
Date of REC Opinion
14 Nov 2013
REC opinion
Favourable Opinion