Status:
TERMINATED
A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Celgene
Conditions:
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
Eligibility Criteria
Inclusion
- Males and females of non-childbearing potential ≥50 years of age (at the time of signing the informed consent document) with documented IPF
- Diagnosis of IPF based on current ATS/ERS guidelines
- Usual interstitial pneumonia (UIP) pattern on HRCT and/or UIP pattern on histopathology (ie surgical lung biopsy), and
- Exclusion of known causes of interstitial lung disease (such as environmental exposure, connective tissue disease and drug toxicity), Or
- UIP pattern on surgical lung biopsy required if HRCT is inconsistent with UIP
Exclusion
- FVC : \< 50% predicted \>90% predicted
- DLco:\< 25% predicted \>90% predicted
- Saturated oxygen (SpO2) of \<92% (room air \[sea level\] at rest). SpO2 of \< 88% (room air \[≥ 5,000 feet above sea level (1524 meters\]) at rest)
- Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 12.5 mg/day or equivalent) including, but not limited to, azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks of screening
- Use of any cytokine modulators:
- Use of any biologic agent (such as etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 12 weeks or five half-lives of screening, and in the case of rituximab, use within 24 weeks of screening or no recovery of CD 19-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to screening
- Alefacept within 24 months of randomization
- Use of any therapy targeted to treat IPF (including but not limited to d-penicillamine, endothelium receptor antagonist \[eg bosentan, ambrisentan\], interferon gamma-1B, pirfenidone) within 4 weeks of screening
- Use of n-acetylcysteine (NAC) for IPF (≥1800 mg/day) within 4 weeks of screening
- Use of any investigational drug within one month of screening, or 5 PD/PK half lives, if known (whichever is longer)
- Current smoker
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01203943
Start Date
January 1 2011
End Date
August 24 2012
Last Update
November 19 2019
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine
Sacramento, California, United States, 95817
3
Stanford University, Pulmonary & Critical Care Clinic
Stanford, California, United States, 94305
4
University of Miami Miller School of Medicine
Miami, Florida, United States, 33101