AZD1208 Safety & Tolerability in Patients with Advanced Solid Tumours
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 AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma
IRAS ID
110061
Contact name
Malcolm Ranson
Sponsor organisation
AstraZeneca AB
Eudract number
2012-001944-23
Clinicaltrials.gov Identifier
Research summary
AstraZeneca is conducting a research study with a new anti-cancer agent called AZD1208 in patients with advanced solid tumours or malignant lymphoma. Studies done in the laboratory have shown that AZD1208 may stop the growth of some abnormal cancer cells, therefore patients may benefit from the study, but there is no guarantee. This study is designed to identify a dose of the drug that can be used in the future. This study will start with a small dose in 3-6 patients in a cohort, and will increase the dose in subsequent cohorts as the study progresses. The study is divided into two phases. In the first phase, the doses of AZD1208 are increased and the safety and tolerability (i.e. side effects) of each dose level determined. Once the maximum tolerated dose is identified, the number of patients studied at that dose level is increased to confirm the suitability of the dose (second part of the study). We are also doing the study to find out how the body handles AZD1208, i.e. how quickly the body absorbs and removes the drug. We will also study how genes (pieces of DNA) affect the way the body responds to or handles it. Patients will be recruited from two clinical centres, one in Japan and one in the United Kingdom. If patients consent to enter this study they will then attend hospital visits throughout the study; the visits will be most frequent during the first 24-28 days of treatment (depending on the length of the washout period). At these visits patients will undergo assessments to check on their health and see how the drug is working. Patients can remain on AZD1208 treatment for as long as they are receiving benefit and are not experiencing side effects.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
12/NW/0617
Date of REC Opinion
28 Sep 2012
REC opinion
Further Information Favourable Opinion