Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00125385
First received: July 29, 2005
Last updated: July 28, 2009
Last verified: December 2007
  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
Idiopathic Pulmonary Fibrosis
Biological: GC1008
Phase 1

Genzyme, a Sanofi Company has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate potential clinical outcomes and bioactivity of GC1008 [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 2005
Study Completion Date: September 2008
Arms Assigned Interventions
Experimental: Cohort 1
Dose group
Biological: GC1008
0.3 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 2
Dose Group
Biological: GC1008
1.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 3
Dose Group
Biological: GC1008
2.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 4
Dose Group
Biological: GC1008
4.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
Experimental: Cohort 5
Dose Group
Biological: GC1008
8.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125385

Locations
United States, Colorado
Denver, Colorado, United States, 80206
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States, 55905
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle, Washington, United States, 98195
Belgium
Belgium, Belgium
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00125385     History of Changes
Other Study ID Numbers: GC100800103
Study First Received: July 29, 2005
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration
Belgium: FPS of Public Health, Food Chain Security and Environment, Directorate-General for Medicinal Products

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on September 22, 2014