Spots Global Cancer Trial Database for LifePearl-Doxo Pharmacokinetic (PK) Study

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Trial Identification

Brief Title: LifePearl-Doxo Pharmacokinetic (PK) Study

Official Title: Pharmacokinetic Study in Patients With Unresectable Hepatocellular Carcinoma (HCC) Receiving Treatment With LifePearl Microspheres Loaded With Doxorubicin

Study ID: NCT02548780

Conditions

HCC

Hepatocellular Carcinoma

Interventions

Chemoembolization

Pharmacokinetics

Study Description

Brief Summary: The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable HCC.

Detailed Description: This is a multicentre, prospective dose escalation/PK study, designed to assess the clinical performance of LifePearl™ beads loaded with Doxorubicin in the primary treatment of unresectable HCC by chemoembolization. Data from this study will be used as supportive data post CE-mark approval. The main objective of the study is to evaluate the safety and pharmacokinetic profile of LifePearl™ beads loaded with Doxorubicin in the treatment of patients with unresectable liver cancer (HCC) by chemoembolization. This will be measured as treatment-related complications and plasma levels of Doxorubicin in peripheral blood. In addition, objective tumour response will be assessed by computed tomography or MRI. Two cohorts of patients will be evaluated: Cohort I to assess safety (dose escalation) and pharmacokinetic profile; Cohort II will assess pharmacokinetic profile, safety and efficacy with the doxorubicin dose determined with Cohort I.