Capivasertib China PK Study

Phase 1

Completed

• Conditions: Advanced Solid Tumours
• Interventions: Drug: Capivasertib; Drug: Paclitaxel

• Registration Number: NCT04742036
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-02-22
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
capivasertib	Paclitaxel	single-dose and multiple-dose capivasertib as monotherapy (Part A) and then in combination with paclitaxel (Part B)
capivasertib	Capivasertib	single-dose and multiple-dose capivasertib as monotherapy (Part A) and then in combination with paclitaxel (Part B)

Primary Outcome Measures

Name	Time	Method
terminal half-life (t1/2) of Capivasertib	first dose up to approximately 6 months	t1/2 is defined as terminal half-life
Area under the plasma concentration-time curve from time zero to 12 hours post-dose (AUC 0-12) of Capivasertib	first dose up to approximately 6 months	AUC0-12 is defined as area under the curve from 0 to 12 hours.
Maximum plasma concentration (Cmax) of Capivasertib	first dose up to approximately 6 months	Cmax is defined as maximum plasma concentration
Accumulation ratio (Rac) of Capivasertib	first dose up to approximately 6 months	Rac is defined as accumulation ratio

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of drugs by assessment of AEs/SAEs	From time of signature of the ICF, through study completion, up to 17 months, and including the 30-day follow-up period after discontinuation of study drug	Graded according to the National Cancer Institute (NCI CTCAE V5.0)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Shanghai, China