Status:

TERMINATED

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

Lead Sponsor:

National Atomic Research Institute, Taiwan

Conditions:

Tumors

Eligibility:

All Genders

20-80 years

Phase:

PHASE1

Brief 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...

Eligibility Criteria

Inclusion

  • Patient with histologically confirmed diagnosis of primary solid tumor, and with pathologically or radiologically documented metastases
  • Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors)
  • Patient with metastatic cancer that are refractory to current standard/available therapies

Exclusion

  • brain metastases
  • serious concurrent infection or nonmalignant illness that is uncontrolled
  • uncontrolled intercurrent illness
  • Immunocompromised
  • significant traumatic injury within 3 weeks before Day 0
  • History of hypersensitivity to any component of study drug

Key Trial Info

Start Date :

October 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2014

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT02271516

Start Date

October 1 2014

End Date

December 1 2014

Last Update

July 30 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Taipei Veterans General Hospital (Taiwain)

Taipei, Taiwan, 11217