Solid Tumours Clinical Trial
Official title:
A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of AZD1775 on the Pharmacokinetics of Substrates for CYP3A, CYP2C19, CYP1A2 and to Provide Data on the Effect of AZD1775 on QT Interval in Patients With Advanced Solid Tumours
The purpose of this study is to determine whether AZD1775 has any effect on the pharmacokinetics (PK) of three compounds (caffeine, omeprazole, and midazolam) that are probes for common drug-metabolizing enzymes (caffeine-CYP1A2, omeprazole-CYP2C19, midazolam-CYP3A). The study also seeks to determine the effect of AZD1775 on the QTc interval, which is a common measure of cardiac (heart) function.
This is a Phase I, 2-part study (Part A and Part B) in patients with advanced solid tumours.
Part A: Part A of this study is an open-label, non-randomised, 2-period design. The treatment
starts with the administration of a cocktail of 3 medications:
caffeine, omeprazole and midazolam (Day -8), followed by pharmacokinetic (PK) sampling for 24
hours (Period 1) and a washout period of at least 7, but no more than 14 days. In Period 2,
AZD1775 will be administered twice daily (bid) until steady state for 2.5 days (total of 5
doses) and the final dose will be administered in combination with the cocktail in the
morning of Day 3.
Part B: Part B is an open-label, non-randomised study in the same patients who participated
in Part A. On Day -1, baseline dECG assessments will be performed at clock times matched to
planned/scheduled dECG assessment times on Days 1 and 3.
Starting on Day 1, each patient will receive AZD1775 (225 mg) bid for 2.5 days and will
undergo dECG and PK assessments pre-dose and for 12 hours post AZD1775 dose.
On Day 3, patients will receive their final AZD1775 dose and undergo dECG and PK assessments
pre-dose and for 12 hours post-dose. On completion of Part B (ie, collection of the 24-hour
PK sample/dECG and safety assessments on Day 4) patients will enter a 4-day washout period
relative to the last dose of AZD1775. Within 3 days after the washout period, patients will
be required to attend an end of treatment (EoT) visit. Patients will be evaluated for their
eligibility and interest to enrol into the open-label continued access (CA) study
(D6014C00007).
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