D2270C00015 (AZD2014), Phase I, Open Label, Advanced Solid Tumours
Research type
Research Study
Full title
A Phase I, Open-Label, Non-randomised, Single Centre Study of the Absorption, Metabolism, Excretion and Pharmacokinetics of AZD2014 After a Single Oral Dose of [14C] AZD2014, Followed by Multiple Doses of AZD2014 Either As Monotherapy or In Combination With Either Fulvestrant or Paclitaxel in Patients With Advanced Solid Malignancies
IRAS ID
179609
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-000198-11
Duration of Study in the UK
1 years, 0 months, 15 days
Research summary
This is a Phase I, open–label, single centre, non-randomised study in participants with advanced solid malignancies. The study will look at the pharmacokinetics (PK - the way that the body handles the drug i.e. absorbs, circulates, breaks down and eliminates it) of AZD2014 after a single oral dose of [14C] AZD2014, followed by multiple doses of AZD2014 either as monotherapy (stand-alone treatment) or in combination with standard therapy of either Fulvestrant (a hormonal drug used to treat breast cancer) or Paclitaxel (a chemotherapy drug given to treat cancers including ovarian, breast and non-small cell lung cancer) in participants with advanced solid malignancies.
AZD2014 is a selective mTOR (Mammalian target of rapamycin - a protein that helps control several cell functions, including cell division and survival, and binds to rapamycin and other drugs) kinase inhibitor (a type of enzyme inhibitor that blocks the action of one or more protein enzymes) targeting both mTORC1 (rapamycin-sensitive) and mTORC2 (rapamycin insensitive) complexes.
The study will be divided in 2 parts, namely a Single Dose Period and a Multiple Dose Period. The study has an optional pharmacodynamics (the effect the drug has on the body) component whereby participants can consent to provide paired tumour biopsies at disease progression to further assess the response to treatment.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0624
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion