drugset / Trial / NCT01980667
Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |