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Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia

NCT01332786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-04-15

No results posted yet for this study

Summary

The purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia.

Conditions

Interventions

DRUG

Tigecycline

Dosage Form: one-hour intravenous infusion Dosage levels, frequency, duration: (3-week cycles) * Level 1: 50 mg daily x 10 doses; 1 week rest * Level 2: 100 mg daily x 10 doses; 1 week rest * Level 3: 150 mg daily x 10 doses; 1 week rest * Level 4: 200 mg daily x 10 doses 1 week rest * Level 5: 250 mg daily x 10 doses; 1 week rest * Level 6: 300 mg daily x 10 doses; 1 week rest * Level 7: 350 mg daily x 10 doses; 1 week rest

Sponsors & Collaborators

Principal Investigators

  • Aaron Schimmer, MD · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-10-31
Completion
2015-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01332786 on ClinicalTrials.gov