CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Lurbinectedin alone +1 moredrug
Likely dose
Lurbinectedin alone 3.2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05063318
NCT05063318Phase 1Completed
CompareCT.gov

An Open-Label, Multicenter Study to Assess the Potential Effects of Itraconazole (a Strong CYP3A4 Inhibitor) on the Pharmacokinetics of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

PharmaMar·interventional·Posted Oct 1, 2021·Updated Sep 2, 2025

In Brief

A Phase 1 clinical trial evaluating Lurbinectedin alone and Lurbinectedin+Itraconazole co-administration for Advanced Solid Tumors. Completed, enrolled 14 participants across 2 sites.

Detailed Summary

Prospective, open-label, two-way crossover, phase Ib drug-drug interaction study in patients with advanced solid tumors

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesSpain
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedOct 1, 2021
Enrollment StartOct 7, 2020
Primary CompletionApr 21, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.8 years ago

Interventions

Lurbinectedin alonedrug

The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.

Lurbinectedin+Itraconazole co-administrationdrug

The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A.