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

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University of Washington

Status and phase

Completed
Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: 100 mg/m2 dose
Drug: 200 mg/m2 dose

Study type

Interventional

Funder types

Other

Identifiers

NCT01093521
US FDA 5R01FD003704 (Other Grant/Funding Number)
35876

Details and patient eligibility

About

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)

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Adult male or female, between 18 and 55 years of age

  2. Documented chronic colonization with Pseudomonas Aeruginosa (Pa)

  3. Confirmed diagnosis of CF:

    1. Documented history of > 60 mmol/L chloride concentration in pilocarpine sweat chloride test And/Or
    2. Genotype with two identifiable mutations consistent with CF, accompanied by one or more phenotypic features consistent with diagnosis of CF
  4. Forced expiratory volume in the first second (FEV1) ≥ 30% of predicted value

  5. Able to expectorate sputum

  6. Serum liver function tests ≤ 2.5 x upper limit of normal

  7. Serum urea nitrogen (BUN) and creatinine ≤ 1.5 x upper limit of normal

  8. Serum creatinine ≤ 2.0 mg/dl

  9. Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC) ≥ 4,500/mm3 and ≤ 15,000/mm3

  10. Ionized calcium ≥ the lower limit of normal

  11. Able to understand and sign the informed consent document, communicate with the Investigator, and comply with the requirements of the protocol

  12. If female and of childbearing potential, must have a negative pregnancy test on Day 1 prior to receiving study drug

  13. If female and of childbearing potential, is willing to use adequate contraception, as determined by the investigator, for the duration of the study

Exclusion criteria

  1. Acute pulmonary exacerbation requiring antibiotic intervention within 2 weeks prior to screening
  2. Osteoporosis defined as the most recent dexa scan within the prior 5 years with a T-score ≤ -2.5
  3. Pregnant or lactating female
  4. Known sensitivity to gallium
  5. Use of biphosphonates
  6. Use of any investigational drug and/or participated in any clinical trial within 3 months prior to screening

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 2 patient groups

100 mg/m2 dose
Experimental group
Description:
Five day continuous IV Gallium Nitrate (Ganite®) infusion at 100 mg/m2
Treatment:
Drug: 100 mg/m2 dose
200 mg/m2 dose
Experimental group
Description:
Five day continuous IV Gallium Nitrate (Ganite®) infusion at 200 mg/m2
Treatment:
Drug: 200 mg/m2 dose

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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