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Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors

NCT05063318 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-09-02

Study results available
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Summary

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

Conditions

Interventions

DRUG

Lurbinectedin alone

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

DRUG

Lurbinectedin+Itraconazole co-administration

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.

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Principal Investigators

  • Sara Martínez Gonzalez, MD · PharmaMar

  • Rubin Lubomirov, MD, PhD · PharmaMar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2022-04-21
Completion
2022-04-21
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063318 on ClinicalTrials.gov