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LifePearl-Iri Pharmacokinetic Study

NCT02547480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-11-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Terumo Europe N.V.

    lead INDUSTRY

Principal Investigators

  • Hans Prenen, MD · Universitair Ziekenhuis Leuven

  • Philippe Pereira, MD · SLK Kliniken Heilbronn GmbH

  • Julien Taieb, MD · Hôpital Georges Pompidou Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-28
Completion
2017-09-19

Countries

  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02547480 on ClinicalTrials.gov