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Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)

NCT02773732 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-08-05

Study results available
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Summary

The purpose of the first part of this study is to establish the maximum tolerated dose (MTD) of oral ciprofloxacin when given in combination with a fixed dose of oral etoposide in patients with resistant acute myeloid leukemia (AML). The purpose of the second part of this study is to determine if the established dose of oral ciprofloxacin in combination with oral etoposide is effective in the treatment of patients with resistant AML.

Conditions

Interventions

DRUG

Ciprofloxacin 750 MG

750 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.

DRUG

Etoposide

Etoposide 200 mg will be taken orally once daily on Days 2 to 8 of each 28-day cycle.

DRUG

Ciprofloxacin 1000 MG

1000 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.

DRUG

Ciprofloxacin 500 mg

500 mg ciprofloxacin will be taken orally twice daily on Days 1 to 10 of each 28-day cycle.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Randall Brown, MD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2021-09-07
Completion
2021-11-15
FDA Drug
Yes

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 NCT02773732 on ClinicalTrials.gov