D081AC00001 Two Part, Phase 1 study in patients with solid tumours

• Research type

  Research Study

• Full title

  A Two-part, Randomised, Open-label, Multicentre, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib Following Single 400 mg Doses of the Capsule Formulation in Patients with Advanced Solid Tumours

• IRAS ID

  129230

• Contact name

  Emma Dean

• Contact email

  emma.dean@christie.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2013-001255-13

• Research summary

  This is a two-part study for patients over 18 years old with advanced solid tumours, who have been unsuccessful with standard treatments for their condition, and are able to eat a high-fat meal. Patients will receive the study drug (Olaparib) in capsule form to be taken orally. No other study drug, comparator or placebo will be given during participation in the study.

  Part A will determine the effect of food on the study drug and to see how quickly it’s absorbed by the body and excreted during the different treatment periods (Pharmacokinetics). Part B will investigate the safety and tolerability of the study drug and will allow the patients to continue receiving the study drug once Part A is complete.

  Part A consists of 3 treatment periods involving a single dose of study drug per period; 1) overnight without food, 2) immediately after a high-fat meal (breakfast) and 3) immediately after a standard meal (breakfast). Patients will be assigned to their starting treatment period/ group at random and will be required to complete all 3 treatment periods. Patients will participate in Part A for between 10 - 28 days. 2 overnight stays are required in each treatment period; from the night before taking the first dose of study drug (Day -1) until the morning of Day 2.

  Patients continuing into Part B will be required to take one dose of study drug twice a day for 6 months.

  During both Parts of the study, the patient will provide blood and urine samples at each study visit. The urine samples are for pregnancy and laboratory safety testing. In Part A, the blood samples are for assessing the level of study drug and safety/ tolerability. In Part B, the blood samples are for assessing safety/ tolerability only.

  At least 24 patients are expected to complete the study.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  13/NW/0411

• Date of REC Opinion

  5 Aug 2013

• REC opinion

  Further Information Favourable Opinion