Spots Global Cancer Trial Database for Capivasertib China PK Study
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Trial Identification
Brief Title: Capivasertib China PK Study
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.
Study ID: NCT04742036
Conditions
Study Description
Brief Summary: 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
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Shanghai, , China
Contact Details
Name: Xichun Hu
Affiliation: Department of Medical Oncology, Fudan University Shanghai Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jian Zhang
Affiliation: Department of Medical Oncology, Fudan University Shanghai Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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