Advanced Solid Tumours Clinical Trial
Official title:
A Phase I Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Capivasertib Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours.
This is an open-label, 2-part Phase I study to assess the PK, safety and tolerability of capivasertib as monotherapy and in combination with paclitaxel in Chinese participants with advanced solid tumours
A Phase I study is designed to assess the PK, safety and tolerability of single-dose and multiple-dose capivasertib as monotherapy (Part A) and in combination with paclitaxel (Part B) in approximately 16 Chinese participants with advanced solid tumours and to detect any differences in the PK profile between Chinese and Caucasian participants due to ethnicity. Descriptive summary will be conducted on the PK analysis set and safety analysis set.The evaluation of capivasertib PK data will be based on the PK analysis set.The assessment on safety and tolerability will be based on the safety analysis set. ;
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|---|---|---|---|
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