drugset

drugset / Trial / NCT01405391

Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks

NCT01405391 ↗

Phase 1 Completed 42 enrolled PharmaMar

NaSingle-groupOpen-labelTreatment

Summary

Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.

Timeline

Start: 2011-11
Primary completion: 2016-01
Completion: 2016-01

Publications

Fernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurbinectedin	Other / unclassified	3 mg	Intravenous

Indications

No indication recorded.