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

  • STATUS
    Recruiting
  • days left to enroll
    60
  • participants needed
    20
  • sponsor
    Hoffmann-La Roche
Updated on 24 July 2022
measurable disease
solid tumor
metastatic malignant solid tumor

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.

Details
Condition Solid Tumors
Treatment Ipatasertib
Clinical Study IdentifierNCT04341259
SponsorHoffmann-La Roche
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

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)
Active congestive heart failure or ventricular arrhythmia requiring medication
Congenital long QT syndrome or corrected QT interval (QTc) > 480 ms
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
Significant traumatic injury within 3 weeks prior to initiation of ipatasertib treatment
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
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
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