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Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

NCT02722538 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-09-18

No results posted yet for this study

Summary

The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).

Conditions

  • Urinary Bladder Cancer

Interventions

DRUG

Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200

TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical drug delivery system, regulated as a drug, whose primary mode of action is the controlled release of gemcitabine into the bladder over a 7-day period.

Sponsors & Collaborators

  • Taris Biomedical LLC

    lead INDUSTRY

Principal Investigators

  • Siamak Daneshmand, MD · University of Southern California

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-05-02
Completion
2019-05-02
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

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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 NCT02722538 on ClinicalTrials.gov