Spots Global Cancer Trial Database for A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors.
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Trial Identification
Brief Title: A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors.
Official Title: A Phase I Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Patients With Locally Advanced Or Metastatic Solid Tumors.
Study ID: NCT04341259
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fudan University Shanghai Cancer Center, Shanghai City, , China
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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