Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515394-10-00

Acronym

PM1183-A-014-15

Enrollment

247

Registered

2024-08-20

Start date

2016-04-26

Completion date

2025-05-21

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selected Advanced Solid Tumors

Brief summary

Phase I Escalation Stage: Determination of MTD and RD, Phase II Expansion Stage: Efficacy

Detailed description

Safety, Pharmacokinetics, Efficacy (Secondary Endpoint in the Phase I Escalation Stage), Pharmacogenomics, Pharmacogenetics

Interventions

DRUGIRINOTECAN

DRUGlurbinectedin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I Escalation Stage: Determination of MTD and RD, Phase II Expansion Stage: Efficacy	—

Secondary

Measure	Time frame
Safety, Pharmacokinetics, Efficacy (Secondary Endpoint in the Phase I Escalation Stage), Pharmacogenomics, Pharmacogenetics	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026