This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.
This is a Phase 1, multicenter, multiple-dose, open-label, nonrandomized study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib following single and multiple dose administration of repotrectinib in patients with advanced cancer. This study will enroll 8 patients each with moderate hepatic impairment, severe hepatic impairment and normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Oral repotrectinib (TPX-0005)
Gabrail Cancer Research Center
Canton, Ohio, United States
Local Institution - 4103
Madrid, Spain
Area under the plasma concentration-time curve (AUC) of repotrectinib
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration
Time frame: Within 22 days of first repotrectinib dose
Maximum Observed Plasma Concentration (Cmax) of repotrectinib
Cmax: Evaluate the maximum plasma concentration
Time frame: Within 22 days of first Repotrectinib dose
Evaluate safety and tolerability
To evaluate the safety and tolerability of repotrectinib in patients with moderate and severe hepatic impairment and patients with normal hepatic function following single and multiple dose administration of repotrectinib assessed by CTCAE v5.0
Time frame: 28 days after last dose of repotrectinib
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