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

NCT ID: NCT02354859

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-02-01

Brief Summary

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

Detailed 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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

5 day of infusion of gallium nitrate

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.

Group Type: ACTIVE_COMPARATOR

Gallium nitrate

Intervention Type: DRUG

Study subjects will receive an infusion of either placebo or gallium nitrate.

5 day of infusion of normal saline

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

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.

Interventions

Gallium nitrate

Study subjects will receive an infusion of either placebo or gallium nitrate.

Intervention Type: DRUG

Normal Saline

Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.

Intervention Type: DRUG

Other Intervention Names

Ga, GaN3O9; Sodium Chloride, NS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Chris Goss

Professor, Medicine/Pulmonary & Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher H Goss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

AL Adult Birmingham / The Children's Hospital Atlanta

Birmingham, Alabama, United States

UC San Diego Medical Center

La Jolla, California, United States

Denver Adult / National Jewish Health

Denver, Colorado, United States

Shands Hospital

Gainesville, Florida, United States

Jackson Memorial Hospital; University of Miami Hospital; University of Miami Hospital and Clinics

Miami, Florida, United States

Atlanta Emory Adult / Emory University Hospital

Atlanta, Georgia, United States

Chicago Northwestern Adult / Northwestern Memorial Hospital

Chicago, Illinois, United States

Iowa City University of Iowa Adult / University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Lexington, KY Adult / University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Portland, ME Adult

Portland, Maine, United States

Baltimore Hopkins Adult / John Hopkins Hospital

Baltimore, Maryland, United States

Boston CHB Adult / Boston Children's Hospital (BCH)

Boston, Massachusetts, United States

Minneapolis CC and Adult / University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States

Omaha Adult / The Nebraska Medical Center

Omaha, Nebraska, United States

Lebanon, NH Dartmouth-Hitchcock CC and Adult / Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cleveland CC and Peds, Hospital of Cleveland

Cleveland, Ohio, United States

Columbus CC and Peds / Nationwide Children's Hospital

Columbus, Ohio, United States

Toledo, OH CC and Peds / The Toledo Hospital; Toledo Children's Hospital

Toledo, Ohio, United States

Oklahoma City Adult / Presbyterian Hospital at OU Medical Center

Oklahoma City, Oklahoma, United States

Pittsburgh Adult, Children's Hospital of Pittsburgh UPMC

Pittsburgh, Pennsylvania, United States

SC CC and Adult Charleston / MUSC

Charleston, South Carolina, United States

Salt Lake City Adult, Intermountain Cystic Fibrosis Center

Salt Lake City, Utah, United States

Seattle UW Adult / University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2R01FD003704-03A1

Identifier Type: FDA

Identifier Source: secondary_id

View Link

STUDY00002609

Identifier Type: -

Identifier Source: org_study_id