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A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients

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ClinicalTrials.gov Identifier: NCT01093521
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : January 12, 2016
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Chris Goss, University of Washington

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Cystic Fibrosis
Interventions Drug: 100 mg/m2 dose
Drug: 200 mg/m2 dose
Enrollment 20
Recruitment Details Subjects were recruited in the Adult cystic fibrosis clinics at 3 centers (the University of Washington, University of Iowa, John's Hopkins University) from the second quarter 2010 and closed February 1, 2012. The study had two dosing cohorts. Cohort 1 completed enrollment in February, 2011. Cohort 2 completed enrollment on February 1, 2012.
Pre-assignment Details We employed no run-in period. No subjects withdrew after randomization.
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description

Five day continuous IV Gallium (Ganite®)infusion

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

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Patients were adults age 18 years but less than 55 years of age with CF and chronic Pseudomonal infection. Patient had to have a baseline FEV1% of predicted greater than or equal to 30%. They had to have been at least 14 days from the end of treatment with intravenous antibiotics for exacerbation. They could not be lactating or pregnant.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
32.8  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
19
  95.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
17
  85.0%
Unknown or Not Reported
2
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
Forced expiratory volume in one second (FEV1) (in liters)  
Mean (Full Range)
Unit of measure:  Liters
Number Analyzed 20 participants
2.25
(1.06 to 4.59)
Forced vital capacity (FVC)(in liters)  
Mean (Full Range)
Unit of measure:  Liters
Number Analyzed 20 participants
3.60
(1.84 to 6.11)
Mean Pseudomonas aeruginosa quantitative sputum culture (CFU's/gr of sputum)  
Mean (Full Range)
Unit of measure:  Million CFU/gr of sputum
Number Analyzed 20 participants
116.7
(0.378 to 866)
1.Primary Outcome
Title Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)
Hide Description

To assess the summed area under the curves of a 5 day infusion of IV Ga from day 1 to day 28 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.

Time Frame Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Gallium (Ganite®) Infusion IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day

Five day continuous IV Gallium (Ganite®)infusion

IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: ug*hr/mL
503  (98) 537  (153)
2.Primary Outcome
Title Number of Serious Adverse Events
Hide Description Safety as measured by serous adverse events
Time Frame 56 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Serious Adverse Events
0
3.Primary Outcome
Title Number of Events When Study Drug Infusion Was Stopped Early
Hide Description Tolerability as measured by adverse events of a 5 day continuous infusion of IV Gallium as assessed by stopping study drug infusion
Time Frame 6 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Number of times study drug interupted
0
4.Secondary Outcome
Title Change in Spirometry From Baseline to Day 8
Hide Description Change in spirometry as measured by FEV1 in liters from baseline to day 8
Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: liters
0.13  (0.18)
5.Secondary Outcome
Title Change in Lung Function From Baseline to Day 15
Hide Description Change in FEV1 in liters from baseline to day 15
Time Frame 15 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: liters
0.13  (0.17)
6.Secondary Outcome
Title Change in Spirometry From Baseline to Day 28
Hide Description Change in lung function as measured by FEV1 in liters from baseline to day 28
Time Frame 28 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: liters
0.10  (0.14)
7.Secondary Outcome
Title Change in Spirometry From Baseline to Day 56
Hide Description Change in lung function as measured by FEV1 in liters from baseline to day 56
Time Frame 56 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
all those subjects enrolled after the amendment to add a day 56 (ITT)
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: liters
0.12  (0.19)
8.Secondary Outcome
Title Change in Spirometry as Measured by FVC From Baseline to Day 8
Hide Description Change from baseline in lung function assessed by FVC in liters after treatment with IV Ga at day 8
Time Frame 8 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: liters
0.16  (0.20)
9.Secondary Outcome
Title Change in P. Aeruginosa Density From Baseline to Day 8
Hide Description Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8
Time Frame 8 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
All available specimens
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: colony counts in millions per gm sputum
21.1  (297.5)
10.Secondary Outcome
Title Change in Sputum P. Aeruginosa Density From Baseline to Day 15
Hide Description Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 15
Time Frame 15 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: colony counts in millions per gm sputum
-5.5  (217.9)
11.Secondary Outcome
Title Change in P. Aeruginosa Density From Baseline to Day 56
Hide Description Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 56
Time Frame 56 days from starting dose
Hide Outcome Measure Data
Hide Analysis Population Description
All available specimens
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description:

Five day continuous IV Gallium (Ganite®)infusion

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

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: colony counts in millions per gm sputum
-76.0  (58.3)
Time Frame 56 days
Adverse Event Reporting Description At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
 
Arm/Group Title IV Gallium (Ganite®) Infusion
Hide Arm/Group Description

Five day continuous IV Gallium (Ganite®)infusion

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

All-Cause Mortality
IV Gallium (Ganite®) Infusion
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IV Gallium (Ganite®) Infusion
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Gallium (Ganite®) Infusion
Affected / at Risk (%) # Events
Total   18/20 (90.00%)    
Blood and lymphatic system disorders   
Lymphadenopathy  [1]  1/20 (5.00%)  1
Congenital, familial and genetic disorders   
Cystic fibrosis lung  [2]  3/20 (15.00%)  3
Ear and labyrinth disorders   
External ear inflammation  [3]  2/20 (10.00%)  2
Gastrointestinal disorders   
Abdominal distension  [4]  1/20 (5.00%)  1
Abdominal pain  [5]  2/20 (10.00%)  2
Gastrointestinal reflux disease  [6]  1/20 (5.00%)  1
Nausea  [7]  1/20 (5.00%)  1
Stomach discomfort  [8]  1/20 (5.00%)  1
vomiting  [9]  1/20 (5.00%)  1
General disorders   
fatigue  [10]  4/20 (20.00%)  4
Peripheral edema  [11]  1/20 (5.00%)  1
pyrexia  [12]  1/20 (5.00%)  1
Infections and infestations   
urinary tract infection  [13]  1/20 (5.00%)  5
Injury, poisoning and procedural complications   
infusion site bruising  [14]  3/20 (15.00%)  3
infusion site hematoma  [15]  1/20 (5.00%)  1
infusion site pain  [16]  1/20 (5.00%)  1
infusion site swelling  [17]  1/20 (5.00%)  1
Investigations   
Blood glucose increased  [18]  1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain  [19]  2/20 (10.00%)  3
Gout  [20]  1/20 (5.00%)  1
Muscle spasms  [21]  1/20 (5.00%)  1
neck stiffness  [22]  1/20 (5.00%)  1
Pain in extremity  [23]  1/20 (5.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Paresthesia   1/20 (5.00%)  2
Nervous system disorders   
Dizziness  [24]  1/20 (5.00%)  1
headache  [25]  9/20 (45.00%)  16
Migraine  [26]  1/20 (5.00%)  1
Renal and urinary disorders   
albuminuria  [27]  1/20 (5.00%)  1
Haematuria   2/20 (10.00%)  2
Pyuria  [28]  1/20 (5.00%)  1
Reproductive system and breast disorders   
Pelvic pain  [29]  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
cough  [30]  4/20 (20.00%)  4
crackles lung  [31]  1/20 (5.00%)  1
Dyspnoea  [32]  2/20 (10.00%)  2
Haemoptysis  [33]  5/20 (25.00%)  5
Nasal congestion  [34]  3/20 (15.00%)  3
Epistaxis  [35]  1/20 (5.00%)  1
Non-cardiac chest pain  [36]  3/20 (15.00%)  3
Productive cough  [37]  3/20 (15.00%)  3
Rhinitis  [38]  2/20 (10.00%)  2
sinus congestion  [39]  3/20 (15.00%)  4
Sinus disorder  [40]  1/20 (5.00%)  1
Sputum discolored  [41]  1/20 (5.00%)  1
Throat irritation  [42]  3/20 (15.00%)  3
Upper respiratory infection  [43]  1/20 (5.00%)  1
Voice alteration  [44]  1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
Rash  [45]  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
Lymphadenopathy
[2]
Cystic fibrosis lung exacerbation
[3]
otitis externa
[4]
Abdominal distension
[5]
Abdominal pain
[6]
Gastrointestinal reflux disease
[7]
Nausea
[8]
Stomach discomfort
[9]
vomiting
[10]
fatigue
[11]
peripheral edema
[12]
fever
[13]
urinary tract infection
[14]
infusion site bruising
[15]
infusion site hematoma
[16]
infusion site pain
[17]
infusion site swelling
[18]
increased blood glucose
[19]
Back pain
[20]
Gout
[21]
Muscle spasms
[22]
Neck stiffness
[23]
Pain in extremity
[24]
dizziness
[25]
headache
[26]
Migraine headache
[27]
albuminuria
[28]
Pyuria
[29]
Pelvic pain
[30]
increased cough
[31]
Crackles heard on lung exam
[32]
Dyspnoea
[33]
Haemoptysis
[34]
Nasal congestion
[35]
Epistaxis
[36]
Non-cardiac chest pain
[37]
Productive cough
[38]
rhinitis
[39]
sinus congestion
[40]
Sinus disorder
[41]
sputum discolored
[42]
Throat irritation
[43]
Upper respiratory tract infection
[44]
Voice alteration
[45]
Rash
The primary limitation of our study was that it was uncontrolled without a blinded placebo. Thus, subjective endpoints could have been biased by either the subjects or the investigators.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
Organization: University of Washington
Phone: 206-543-3166
EMail: goss@u.washington.edu
Layout table for additonal information
Responsible Party: Chris Goss, University of Washington
ClinicalTrials.gov Identifier: NCT01093521     History of Changes
Other Study ID Numbers: 35876
US FDA 5R01FD003704 ( Other Grant/Funding Number: FDA )
First Submitted: March 24, 2010
First Posted: March 26, 2010
Results First Submitted: September 15, 2014
Results First Posted: January 12, 2016
Last Update Posted: January 29, 2019