Status:
COMPLETED
A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 partici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04341259
Start Date
November 3 2020
End Date
April 6 2023
Last Update
May 8 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200120