GC100800103: Study of GC1008 in Patients with Idiopathic Pulmonary Fibrosis (IPF)

This study is currently recruiting patients.

Sponsored By:	Genzyme Cambridge Antibody Technology Group, PLC
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00125385

Purpose

This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.

Condition	Intervention	Phase
Pulmonary Fibrosis	Drug: GC1008, Human Anti-Transforming Growth Factor-b 1, 2, 3 mAb	Phase I

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Safety Study

Official Title: Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic Study of GC1008 in Patients with IPF

Further Study Details:

Primary Outcomes: To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF

Secondary Outcomes: To evaluate potential clinical outcomes and bioactivity of GC1008

Study Start: 2005-07; Expected Completion: 2006-10

Eligibility

Ages Eligible for Study: 18 Years - 79 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Willing and able to provide written informed consent prior to any study-related procedures.

Patients should have an established diagnosis of IPF.

Pulmonary Function Tests (PFTs): FVC ≥ 50% and DLCO ≥ 25% of normal predicted values.

Able to walk at least 500 feet (150 meters) during the 6-minute Walk Test (6MWT). During the 6MWT the patient must not require greater than 51/min supplemental oxygen to maintain oxygen saturation > 80%

Exclusion Criteria

Women who are pregnant or lactating; or who plan to become pregnant within 9 months after the infusion.

Women of childbearing potential or men who are considering fathering a child unless taking medically acceptable contraceptive precautions; (A woman of childbearing potential is defined as any female who is not at least 2 years without menses or has not undergone a hysterectomy or surgical sterilization; For women, acceptable contraceptive precautions are combined or progestogen-only oral contraceptive pill, intrauterine device, depot progestogen, or exclusive relationship with a partner who has had a vasectomy. Barrier methods alone are not acceptable for men or women. Female partners of male participants should use an acceptable contraceptive precaution.

History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin.

History of clinically significant respiratory diseases other than IPF.

History of clinically significant cardiac, hepatic, or renal disease.

History of cancer, precancerous state (e.g. familial polyposis, BRCA1, BRCA2), other than non-melanomatous skin cancer, within 5 years prior to Screening.

Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening.

Other pathology that might interfere with the assessment of the safety or efficacy of the test article.

Other clinically significant, uncontrolled medical condition that, in the Investigator’s opinion, might interfere with the assessment or follow-up.

Location Information

Please refer to this study by ClinicalTrials.gov identifier NCT00125385

Colorado
National Jewish Medical and Research Center, Denver, Colorado, 80206, United States; Recruiting

Illinois
The University of Chicago, Chicago, Illinois, 60637, United States; Recruiting

Michigan
University of Michigan Medical School, Ann Arbor, Michigan, 48109, United States; Recruiting

Minnesota
Mayo Clinic College of Medicine, Rochester, Minnesota, 55905, United States; Recruiting

Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States; Recruiting

Washington
University of Washington Medical Center, Seattle, Washington, 98195, United States;Recruiting

More Information

Study ID Numbers: GC100800103
ClinicalTrials.gov Identifier: NCT00125385
Health Authority: United States: Food and Drug Administration