A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors.

Inclusion criteria

• Histologically documented locally advanced or metastatic solid tumor that has progressed or failed to respond to at least one prior regimen.
• Not a candidate for regimens known to provide clinical benefit.
• Evaluable or measurable disease according to RECIST, v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
• Life expectancy of >= 12 weeks.
• Adequate haematologic and organ function within 14 days prior to initiation of study treatment.
• Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs.
• Men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
• Participants must reside in the People's Republic of China

Exclusion criteria

• Leptomeningeal disease as the only manifestation of the current tumor.
• Type 1 or 2 diabetes mellitus requiring insulin at study entry.
• Inability or unwillingness to swallow pills.
• Malabsorption syndrome or other condition that would interfere with enteral absorption.
• Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants for symptomatic control).
• Congenital long QT syndrome or corrected QT interval (QTc) > 480 ms.
• Active congestive heart failure or ventricular arrhythmia requiring medication.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring weekly paracentesis for 3 consecutive weeks prior to initiation of ipatasertib treatment.
• Severe infections within 4 weeks prior to screening including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
• Requirement for any daily supplemental oxygen.
• History of Inflammatory bowel disease or active bowel inflammation.
• Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy.
• Clinically significant history of liver disease, including viral disease or hepatitis,current alcohol abuse or cirrhosis.
• Known HIV infection.
• Active (chronic or acute) hepatitis C virus (HCV) at screening.
• Hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test or a positive quantitative HBV DNA test at screening
• Significant traumatic injury within 3 weeks prior to initiation of ipatasertib treatment.
• Major surgical procedure within 4 weeks prior to initiation of ipatasertib treatment.
• Treatment with chemotherapy, immunotherapy, or biologic therapy as cancer therapy within 3 weeks prior to initiation of ipatasertib treatment.
• Use of strong CYP3A4 inhibitors within 4 weeks prior to initiation of ipatasertib treatment.
• Oral endocrine therapy within 2 weeks prior to initiation of ipatasertib treatment.
• Prior treatment with a PI3-kinase inhibitor in which the patient experienced a Grade >= 3 drug-related adverse event or otherwise would be at increased risk for additional PI3K-related toxicity.
• Palliative radiation to bony metastases within 2 weeks prior to initiation of ipatasertib treatment.
• Radiotherapy (other than palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of ipatasertib treatment.
• Treatment with an investigational agent within 4 weeks prior to initiation of ipatasertib treatment.
• Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
• Pregnant or lactating.
• Inability to comply with study and follow-up procedures.