AZD2014 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 Efficacy of the mTor Kinase Inhibitor AZD2014 Administered Orally to Patients with Advanced Solid Malignancies

• IRAS ID

  29761

• Contact name

  Udai Banerji

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2009-015244-42

• ISRCTN Number

  N/A

• Research summary

  AstraZeneca is conducting a research study with a new anti-cancer agent called AZD2014 in patients with advanced cancers. Studies done in the laboratory have shown that AZD2014 helps stop the growth of some human cancer cells, therefore patients may benefit from participating in 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. As this study drug has never been given to humans before, it will start with a small dose given to a small group (cohort) of patients. If this dose is tolerated, the dose increases in subsequent cohorts of patients, as the study progresses. The study is divided into two parts. In Part A, the doses of AZD2014 are increased and the safety and tolerability (i.e. side effects) to 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 (Part B of the study). We are also doing the study to find out how the body handles AZD2014 (i.e. how quickly the body absorbs and removes the drug) and how genes (building blocks of cells) affect the way the body responds to or handles the drug. Patients will be recruited from 2-3 clinical centres in Europe. 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 28 days of treatment and there may be potential overnight admissions. At visits, patients will undergo assessments to check on their health and see how the drug is working. Patients can remain on AZD2014 treatment for as long as they are receiving benefit and are not experiencing unacceptable side effects.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/88

• Date of REC Opinion

  5 Nov 2009

• REC opinion

  Favourable Opinion