AZD9496 First Time in Patients Ascending Dose Study
Research type
Research Study
Full title
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 in Women with Estrogen Receptor Positive HER-2 Negative Advanced Breast Cancer
IRAS ID
165936
Contact name
Kate Beaujeaux
Sponsor organisation
AstraZeneca AB
Eudract number
2014-003499-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 14 days
Research summary
Breast cancer is a life threatening disease and is the second leading cause of cancer death among women. Approximately 80% of post-menopausal women with breast cancer have estrogen receptor positive (ER+) disease. Endocrine therapy is the standard of care for ER+ patients and has been shown to improve prognosis. Despite initial efficacy seen with endocrine therapies such as anti-hormonal agents that directly block ER function or therapies that block the production of estrogen itself (e.g. aromatase inhibitors), acquired resistance ultimately limits the use of these agents. Therefore, novel endocrine therapies are needed in this setting.
AZD9496 is an investigational oral therapy which is being developed. It has not yet been approved for use by the regulatory authorities and therefore this study is part of a research project. This study is being carried out to investigate the safety and tolerability of ascending doses of AZD9496 in women with advanced breast cancer.
In this first in human study, AZD9496 will be administered to patients whose disease has progressed following prior therapy. There are two parts to this study, A) dose escalation and B) dose expansion:
A) Cohorts of 3-6 evaluable patients will be enrolled into the dose escalation phase. The number of patients in the dose escalation phase will depend on the number of patients recruited per cohort and the number of dose escalations necessary. The dose escalation phase of the study will determine the maximum tolerated dose (MTD), or maximum feasible dose (MFD), of AZD9496 based upon assessment of the safety, tolerability and pharmacokinetic data collected during the first 21 days of daily dosing.
B) Based on emerging data, expansion cohorts at selected doses will include approximately 6 evaluable patients to further investigate the safety, tolerability, PK and biological activity of the study drug.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1374
Date of REC Opinion
12 Dec 2014
REC opinion
Further Information Favourable Opinion