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Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients

NCT02307487 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-06-16

No results posted yet for this study

Summary

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations.

Conditions

Interventions

DRUG

140 mg MMC in 90ml gel

140 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel

DRUG

160 mg MMC in 90ml gel

160 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel

DRUG

120 mg MMC in 60ml gel

120 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel

DRUG

140 mg MMC in 60ml gel

140 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel

DRUG

160 mg MMC in 60ml gel

160 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel

DRUG

120 mg MMC in 90ml gel

120 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel

Sponsors & Collaborators

  • UroGen Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Ifat Klein, PhD · UroGen Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-04-30
Completion
2017-06-30

Countries

  • Israel

Study Locations

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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 NCT02307487 on ClinicalTrials.gov