Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varyin… (NCT05101265) | Clinical Trial Compass
UnknownPhase 1
Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment
Spain24 participantsStarted 2021-03-09
Plain-language summary
Lurbinectedin is mainly eliminated by the liver. Thus, Hepatic Impairment (HI) may alter the plasma concentrations of lurbinectedin. This study is designed to examine the PK and safety of an adjusted dose of lurbinectedin when administered to patients with HI. The results of this study may be used to support future clinical studies in patients and prescribing information in future labeling.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary signed and dated written informed consent prior to any specific study procedure.
✓. Male or female with age ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
✓. Life expectancy \> 1 month.
✓. Pathologically confirmed diagnosis of advanced solid tumors \[except for primary central nervous system (CNS) tumors\], for which no standard therapy exists.
✓. Recovery to grade ≤ 1 from drug-related adverse events (AEs) of previous treatments, excluding alopecia and/or cutaneous toxicity and/or peripheral neuropathy and/or fatigue grade ≤ 2, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v.5).
✓. Laboratory values within fourteen days prior to registration:
✓. Absolute neutrophil count (ANC) \> 2.0 x 10\^9/L, platelet count \> 120 x 10\^9/L and hemoglobin \> 9.0 g/dL (patients may be transfused as clinically indicated prior to study entry).
Exclusion criteria
✕. Concomitant diseases/conditions:
✕. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular disease within last year.
✕. Symptomatic arrhythmia or any uncontrolled arrhythmia.
What they're measuring
1
Total plasma dose-normalized Cmax
Timeframe: Preinfusion, 5 minutes before end of infusion, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, 96 hours, 168 hours, 240 hours, 336 hours, and 504 hours after end of infusion
2
Total plasma dose-normalized AUC0-48h
Timeframe: Preinfusion, 5 minutes before end of infusion, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, 96 hours, 168 hours, 240 hours, 336 hours, and 504 hours after end of infusion
3
Total plasma dose-normalized AUC0-∞
Timeframe: Preinfusion, 5 minutes before end of infusion, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, 96 hours, 168 hours, 240 hours, 336 hours, and 504 hours after end of infusion
. Active infection by hepatitis B virus (HBV) or hepatitis C virus (HCV), defined as: for hepatitis B, positive test for quantitative Hepatitis B virus polymerase chain reaction (PCR or HBV-DNA+), regardless of the HBsAg; and for hepatitis C, positive test for quantitative Hepatitis C virus by PCR (or HCV-RNA+).
✕. Human immunodeficiency virus (HIV)-positive patients.
✕. History of Gilbert's syndrome diagnosis.
✕. History of biliary sepsis in the past 2 months.
✕. Patients with biliary obstruction for which a stent has been placed are eligible, provided the stent has been in place for at least 10 days prior to the first dose of lurbinectedin and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction cohort will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis.