drugset / Trial / NCT01980667

Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors

NCT01980667

Phase 1 Completed 41 enrolled PharmaMar
NaSingle-groupOpen-labelTreatment

Summary

Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (PGx) analysis.

Timeline

Start
2014-07-30
Primary completion
2017-01-05
Completion
2017-01-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 60 mg/m2 Intravenous
Subject Lurbinectedin Other / unclassified 1.1 mg/m2 Intravenous
Subject Lurbinectedin Other / unclassified 1.4 mg/m2 Intravenous

Indications