Capivasertib China PK Study

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 22, 2021

Primary Completion Date

July 29, 2022

Study Completion Date

July 29, 2022

Conditions
Advanced Solid Tumours
Interventions
DRUG

Capivasertib

Part A Cycle 0: Single dose 480 mg(3 x 160 mg tablets) on Day 1 of Cycle 0 Cycle 1 (monotherapy): 480 mg(3 x 160 mg tablets) twice daily given on an intermittent weekly dosing schedule (4 days on, 3 days off for 7 days) Part B Cycle 2 (in combination therapy with paclitaxel): 400 mg (2 x 200 mg tablets) twice daily given on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib treatment will continue until disease progression, unacceptable toxicity or the participant requests to stop treatment.

DRUG

Paclitaxel

"Part B Cycle 2: Patients will receive 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.~Paclitaxel treatment will continue for at least 6 cycles, unless the participant experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel, or disease progression."

Trial Locations (1)

200032

Research Site, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY