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Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

NCT02611024 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2025-07-09

No results posted yet for this study

Summary

Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.

Conditions

Interventions

DRUG

Lurbinectedin

lurbinectedin (PM01183) 4 mg vials

DRUG

Irinotecan

irinotecan 40 mg, 100 mg or 300 mg vials

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-06
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT02611024 on ClinicalTrials.gov