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Clinical trialNCT05101265UnknownPhase 1Interventional

Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment

SponsorPharmaMarEnrollment24Advanced Solid TumorHepatic Impairment
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Spain
  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, Spain

    Recruiting
  • Hospital Universitari Vall D'Hebron

    Barcelona, Catalonia, Spain

    Recruiting
  • Hospital General Universitario Gregorio Marañón

    Madrid, Spain

    Recruiting
  • Hospital Universitario Fundación Jimenez Diaz

    Madrid, Spain

    Recruiting
  • Hospital Universitario Hm Sanchinarro

    Madrid, Spain

    Recruiting
  • Hospital Universitario Ramón Y Cajal

    Madrid, Spain

    Active, not recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 Mar 2021
Primary completion
1 Jun 2025
Completion
1 Jun 2025
Last update posted
27 Nov 2023
Registered enrollment
24
Registry id
NCT05101265

Cross-registrations

EU-CTR / CTIS (EudraCT)2020-002789-14

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.