Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT01980667
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors
Sponsor:
PharmaMar
Organization:
Study Overview
Official Title:
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: