NCT02547480

LifePearl-Iri Pharmacokinetic Study

Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.

Conditions

• Metastatic Colorectal Cancer
• mCRC

Interventions

Type	Name	Description
DEVICE	TACE with irinotecan loaded LifePearl	Arterial embolization will be performed through lobar infusion and using a microcatheter. LifePearl microspheres of 200 µm will be used as preferred beads. They will be loaded with the appropriate dose of irinotecan hydrochloride injectable solution, mixed with the contrast media and distributed to the targeted lobe. The targeted dose is 100 mg of irinotecan per lobe treated, meaning that when treated unilobarly at baseline the total dose received will be 100 mg ( all in one lobe) and in during bilobar treatment, 200 mg in both lobes.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-04-28
• Completion: 2017-09-19
• First posted: 2015-09-11
• Last updated: 2017-11-27

Locations

3 sites across 2 countries: Belgium, Germany