CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
100 mg/m2 dose +1 moredrug
Likely dose
100 mg/m2 dosefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01093521
NCT01093521Phase 1Completed
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A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients

University of Washington·interventional·Posted Mar 26, 2010·Updated Nov 29, 2022

In Brief

A Phase 1 clinical trial evaluating 100 mg/m2 dose and 200 mg/m2 dose for Cystic Fibrosis. Completed, enrolled 20 participants across 3 sites.

Detailed Summary

The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the drug are found in the sputum. Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsCystic Fibrosis Foundation

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2010
Enrollment StartApr 1, 2010
Primary CompletionApr 1, 2012
Study CompletionAug 31, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.3 years ago

Interventions

100 mg/m2 dosedrug

5 day infusion of gallium nitrate (IV Ganite®) at a dose of 100 mg/m2/day

200 mg/m2 dosedrug

5 day infusion of gallium nitrate (IV Ganite®) at 200 mg/m2/day