A Phase I, Open-Label study designed to assess the pharmacokinetics (PK), safety and tolerability of ipatasertib in Chinese participants. Approximately 20 Chinese participants (12 PK-evaluable participants) with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven ineffective will be enrolled to provide sufficient data. Participants will receive a 400-mg ipatasertib dose (two 200-mg tablets) daily orally (PO). Participants deriving clinical benefit may be offered continued treatment with ipatasertib until disease progression, at the discretion of the investigator (as assessed by the investigator) or until the study is terminated by the Sponsor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Participants will receive a 400-mg Ipatasertib dose (two 200-mg tablets) orally (PO) daily (QD) as described above.
Fudan University Shanghai Cancer Center
Shanghai, China
AUC (0-inf) after a single dose and AUC (0-24) after single and multiple doses of Ipatasertib
Time frame: Up to 25 months
Maximum plasma concentration (Cmax) of Ipatasertib
Time frame: Up to 25 months
Minimum plasma concentration (Cmin) of Ipatasertib after multiple doses of Ipatasertib
Time frame: Up to 25 months
Time to maximum plasma concentration (tmax) of Ipatasertib
Time frame: Up to 25 months
Terminal half-life (t1/2) of Ipatasertib and GO37220
Time frame: Up to 25 months
Apparent clearance (CL/F) of Ipatasertib and GO37220 after single and multiple doses of Ipatasertib
Time frame: Up to 25 months
Accumulation ratio at steady state (Rcmax) of Ipatasertib
Accumulation ratio will be calculated as follows: Rcmax = AUC24h,ss/AUC0-24 of Day 1.
Time frame: Up to 25 months
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessed by the NCI CTCAE v5.0 criteria.
Time frame: Up to 25 months
Percentage of Participants with Adverse Events leading to Study Treatment Discontinuation, Modification or Interruption
Time frame: Up to 25 months
Number of Deaths
Time frame: Up to 25 months
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