NCT02271516

to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage

A Phase I, Open-label, Dose-escalation Study to Determine the Maximum Tolerance Dose (MTD) and to Evaluate the Safety of 188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: National Atomic Research Institute, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of 188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.

Detailed description

Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.

Conditions

• Tumors

Interventions

Type	Name	Description
RADIATION	188Re-BMEDA-liposome	EKG at baseline and in 24hours after administration

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-10-22
• Last updated: 2020-07-30

Locations

1 site across 1 country: Taiwan