Advanced Solid Tumours Clinical Trial
Official title:
A Phase I, Open Label, 2 Part Study to Determine the Pharmacokinetics of Olaparib 300 mg bd Administered as Monotherapy and Olaparib 100 mg bd as Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours
This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours. Part A will assess the single and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2
Part A will access the pharmacokinetics of olaparib: Cohort 1 will investigate the single and
multiple dose pharmacokinetics of olaparib following 300mg bd monotherapy dose(s); Cohort 2
will investigate the single and multiple dose pharmacokinetics of olaparib following 100mg bd
monotherapy dose(s) and the multiple dose pharmacokinetics in the presence of co-administered
paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle).
In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in
combination with weekly paclitaxel will also be investigated in Chinese patients.
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