Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02210364
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2014-08-05
Brief Title:
Study of Lurbinectedin PM01183 in Combination With Capecitabine in Patients With Metastatic Breast Cancer MBC Pancreatic Cancer PC or Metastatic Colorectal Cancer CRC
Sponsor:
PharmaMar
Organization:
PharmaMar
Study Overview
Official Title:
Phase I Multicenter Open-label Clinical and Pharmacokinetic Study of Lurbinectedin PM01183 in Combination With Capecitabine in Patients With Unresectable Metastatic Breast Cancer MBC Pancreatic Cancer PC or Metastatic Colorectal Cancer CRC
Status:
COMPLETED
Status Verified Date:
2016-05
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:
Phase I Multicenter Open-label Clinical and Pharmacokinetic Study of Lurbinectedin PM01183 in Combination with Capecitabine in Patients with Unresectable Metastatic Breast Cancer MBC Pancreatic Cancer PC or Metastatic Colorectal Cancer CRC to determine the recommended dose RD of PM01183 in combination with capecitabine to characterize the safety profile to explore the feasibility of PM01183 dose optimization to characterize the pharmacokinetics PK to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic PGx analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None