MedTrace Logo

Compassionate Use of MitoGel in Upper Tract Urothelial Carcinoma

NCT02701023 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2017-09-14

No results posted yet for this study

Summary

The aim of this study is to evaluate the feasibility, safety, and efficacy of MitoGel in the treatment of UTUC in a human subject with low-grade UTUC which is endoscopically unresectable or rapidly recurring, and in whom nephrectomy would likely result in the need for permanent hemodialysis. The study drug would be obtained under the single patient access program approved by the FDA. The patient would then undergo instillation of MitoGel into the affected kidney. The catheter would be left indwelling in the ureter and would be externalized. The ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments, which would occur twice weekly for 3 weeks or once weekly for 6 weeks. Following the final instillation, the catheters would be removed. The patient would then undergo ureteroscopic evaluation at 3 months following the final instillation of MitoGel. The total duration of study would be 3 months. The total number of study patients is 1.

Conditions

  • Urothelial Carcinoma Ureteral Location

Interventions

DRUG

MitoGel

The patient would then undergo instillation of MitoGel into the affected kidney. The catheter would be left indwelling in the ureter and would be externalized through a urethral catheter. The ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments, which would occur twice weekly for 3 weeks. Following the final instillation, the catheters would be removed. The patient would then undergo ureteroscopic evaluation at 3 months following the final instillation of MitoGel. The total duration of study would be 3 months.

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Eligibility

Min Age
76 Years
Max Age
77 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

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 NCT02701023 on ClinicalTrials.gov