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A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy

NCT01234519 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-03-15

No results posted yet for this study

Summary

The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.

Conditions

Interventions

DRUG

AEZS-108

128, 160, 210 or 267 mg/m2, 2-hour intravenous (IV) infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles

DRUG

AEZS-108 at MTD

2-hour IV infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • Miami VA Healthcare System

    collaborator FED

  • University of Miami Sylvester Comprehensive Cancer Center

    collaborator OTHER

  • AEterna Zentaris

    lead INDUSTRY

Principal Investigators

  • Gustavo Fernandez, MD · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01234519 on ClinicalTrials.gov