A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
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 - FDA OOPD
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients|
- Pharmacokinetic, safety, and tolerability assessment of a 5 day infusion of gallium nitrate (IV Ganite®) [ Time Frame: 56 days ] [ Designated as safety issue: No ]
To assess the pharmacokinetics of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.
To assess the safety of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.
Safety and tolerability of 5 days of treatment with IV administered gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day.
- Change in spirometry, change in sputum microbiology [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Change in spirometry from baseline to day 8, from baseline to day 15 and from baseline to day 56.
Change from baseline in FEV1 after treatment with IV Ga. Change from baseline in FVC after treatment with IV Ga.
Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8, from baseline to day 15, and from baseline to day 56
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||September 2018|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: IV Gallium (Ganite®) infusion
Five day continuous IV Gallium (Ganite®)infusion
Drug: IV Gallium Nitrate (Ganite®) infusion
5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day
This is a two center pharmacokinetic and safety dosing study of IV gallium nitrate (Ganite®) in cystic fibrosis (CF) patients. Eighteen subjects are planned. Each subject will be administered a single 5-day infusion of study medication (one of 2 doses). No placebo is used. Each subject will receive 5 days of continuous infusion of the experimental treatment. There will be two dosing cohorts (cohort 1: 100 mg/m2/day and cohort 2: 200 mg/m2/day). Cohort 2 will begin enrollment only after Data Safety Monitoring Committee (DSMC) safety review and approval of cohort 1 data. Study visits occur at baseline (day 1), day 3 (visit 2), day 6 (visit 3), day 8 (visit 4), day 14 (visit 5), day 28 (visit 6), and day 56 (visit 7).
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The following treatment regimens will be used:
• Experimental treatment continuous infusion of gallium nitrate at the following doses cohort 1: 100 mg/m2/day and cohort 2: 200 mg/m2/day All subjects who receive at least one dose of study medication will be considered evaluable for safety and efficacy analyses. Incidence of adverse events will be monitored during the trial.
Primary endpoints will be assessment of pharmacokinetic and safety/tolerability data.
Secondary efficacy assessments will be based on changes in lung function and sputum P. aeruginosa density in sputum.
Total duration of subject participation will be five weeks. Total duration of the study is expected to be 20 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093521
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242-1083|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21201|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Christopher H Goss, MD, MSc||University of Washington|