AZ: D0816C00004 Ph 1 - Effect of Food in Advanced Solid Tumours
Research type
Research Study
Full title
A Randomised, Open-label, Three-part, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib and to Provide Data on the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients with Advanced Solid Tumours
IRAS ID
131419
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-001891-39
ISRCTN Number
N/A
Research summary
This is a three part study for patients over 18 years old with advanced solid tumours, whose tumours have failed to respond to standard treatments and are able for part A only to eat a high-fat meal. Patients will receive the study drug Olaparib in tablet form which will be taken orally. No other study drug, comparator or placebo will be given during participation in the study. Part A will determine whether food affects the absorption and exretion (pharmacokinetics) of Olaparib during the different treatment periods as well as the effect of Olaparib on the heart's electrical (QT interval) following a single oral dose of Olaparib. This will allow us to advise patients how to take Olaparib in relation to food, i.e. before or after meals and if or how often , the heart's electrical activity needs to be monitored for patients taking Olaparib.
Part A consists of two treatment periods lasting between five and 14 days involving a single dose of study per treatment period, one with ad one without food. Patients will be assigned to their starting treatment period at random and will be required to complete the two treatment periods in a crossover fashion with a washout period in between. Part A will require patients to attend seven visits over an approximate two week period, which will include five overnight stays. Patients will be required to fast three times during that period for the two days preceding the first Olaparib dose on and day -1 preceding the second Olaparb dose.
Part B will investigate the effect of Olaparib on the heart's electrical activity (QT interval) following multiple oral doses of Olapaib. Part B will require patients to attend two visits, the first two days before starting the Olaparib five days treatment period and the second visit on day four of the five day treatment phase. Both visits require an overnight stay. Patient will be required to fast on each of these overnight stays. Many ECG's (tracings of the heart's electrical activity) and blood samples to measure the amount of Olaparib in the blood will be taken during parts A and B. Some of the blood samples are for assessing safety tolerability. The urine samples are for pregnancy and laboratory safety testing.
Part C will allow patients continued access to Olaparib after PK and QT phases and will provide for additional safety and tolerability data collection. Patients may receive therapeutic benefit during continuous dosing with Olaparib but this is not guaranteed. Patients will have weekly safety visits to the clinic for the first month and then monthly visits thereafter for approximately 12 months. If the patient and the investigator agree that the patient is receiving benefit from treatment with Olaparib after 12 months' treatment, the patient may continue treatment with Olaparib. A total of 48 patients are expected to complete the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0186
Date of REC Opinion
2 Jul 2013
REC opinion
Favourable Opinion