Trials / Completed
CompletedNCT01980667
Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lurbinectedin (PM01183) | lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials. |
| DRUG | Cisplatin | vials containing 1 mg/ml concentrate for solution for infusion |
Timeline
- Start date
- 2014-07-30
- Primary completion
- 2017-01-05
- Completion
- 2017-01-05
- First posted
- 2013-11-11
- Last updated
- 2017-01-26
Locations
3 sites across 2 countries: Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01980667. Inclusion in this directory is not an endorsement.