A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)

University of Washington

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Normal Saline; Drug: Gallium nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02354859

STUDY00002609

2R01FD003704-03A1

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28.

Funding Source - FDA OOPD

Full description

This is a phase 2, multi-center, randomized, placebo-controlled trial in adults with CF chronically infected with P. aeruginosa. The study will evaluate the safety and clinical efficacy of a five day infusion of IV gallium nitrate (IV gallium). The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age at Screening

• Documented chronic colonization with P. aeruginosa defined as dentification in two sputum or oropharyngeal cultures within the year prior to Day 1

• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

  1. sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
  2. two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
  3. Abnormal nasal potential difference (NPD; change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)

• FEV1 ≥ 25 % of predicted value at Screening

• Able to expectorate sputum

• Serum liver function tests ≤ 2.5 x upper limit of normal at Screening

• Serum urea nitrogen (BUN) ≤ 1.5 x upper limit of normal at Screening

• Serum creatinine ≤ 2.0 mg/dl and ≤ 1.5 x upper limit of normal at Screening

• Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC)

  ≥ 4,500/mm3 at Screening

• Ionized calcium ≥ lower limit of normal at Screening

• Written informed consent obtained from subject or subject's legal representative

• Able to communicate with the Investigator and comply with the requirements of the protocol

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

• If female and of childbearing potential, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator

• If male and able to father a child, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator

• Clinically stable with no significant changes in health status within 14 days prior to Day 1

Exclusion criteria

• Use of inhaled antibiotics within seven days prior to Day 1
• Unable or unwilling to withhold use of chronic inhaled antibiotics through Day 28
• Use of intravenous, inhaled, or oral antibiotics for an acute indication within 14 days prior to Day 1
• Use of bisphosphonates within seven days prior to Day 1
• History of osteoporosis (defined as the most recent dexa scan with a T-score ≤ -2.5 with the dexa scan performed within the five years prior to Screening)
• Lactating female
• Known sensitivity to gallium

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 2 patient groups, including a placebo group

5 day of infusion of gallium nitrate

Active Comparator group

Description:

Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.

Treatment:

Drug: Gallium nitrate

5 day of infusion of normal saline

Placebo Comparator group

Description:

Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga

Treatment:

Drug: Normal Saline