NCT02210364

Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: PharmaMar · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer
• Pancreatic Cancer
• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	lurbinectedin (PM01183)	lurbinectedin (PM01183) 1 mg and 4 mg vials
DRUG	capecitabine	capecitabine 150 mg tablets

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-08-06
• Last updated: 2016-12-14

Locations

2 sites across 2 countries: Belgium, Spain