Pharmacokinetics and FDG PET Scan with AKT Inhibitor

• Research type

  Research Study

• Full title

  An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects with Ovarian Cancer

• IRAS ID

  45901

• Contact name

  Hani Gabra

• Sponsor organisation

  Imperial College London

• Eudract number

  2009-016518-25

• ISRCTN Number

  not issued

• Research summary

  The purpose of this study is to explore the potential relationship between the pharmacokinetics of GSKXXXXX and [18F] FDG-PET pharmacodynamic markers of glucose metabolism in tumours. Three to six subjects will be enrolled in four cohorts and dosed with repeat escalating doses of GSKXXXXX. [18F]FDG-PET imaging and optional tumor biopsies will be done prior to initiation of dosing and sequentially at select time points during the first five weeks of dosing. The maximal dose evaluated in this study will not exceed the maximal tolerated dose established in the first-time-in-human trial reference (ClinicalTrials.gov Identifier NCT00920257).

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/19

• Date of REC Opinion

  20 Apr 2010

• REC opinion

  Further Information Favourable Opinion