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A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT01203943
Recruitment Status : Terminated (The benefit/ risk profile does not support continuation of this study.)
First Posted : September 17, 2010
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Brief Summary:
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Fibrosis Interstitial Lung Disease Lung Diseases, Interstitial Drug: CC-930 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
Study Start Date : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : August 2012


Arm Intervention/treatment
Experimental: Cohort 1
• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM.
Drug: CC-930
CC-930 50 mg PO daily up to 56 weeks beginning on Day 1

Experimental: Cohort 2
• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM
Drug: CC-930
CC-930 100 mg PO daily up to 56 weeks beginning on Day 1

Experimental: Cohort 3
• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1.
Drug: CC-930
C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1

Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Safety [ Time Frame: Week 4 ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. Long-term safety [ Time Frame: Weeks 52-104 ]
    Number of participants with adverse events

  2. Disease progression/death rates [ Time Frame: Up to week 56 ]
    Time to disease progression and death

  3. Disease progression/death rates [ Time Frame: Weeks 52-104 ]
    Time to disease progression and death from week 52

  4. Pharmacokinetics-Cmax [ Time Frame: Week 1 (baseline) and week 2 ]
    Maximum observed concentration in plasma

  5. Pharmacokinetics-Cmin [ Time Frame: Week 0 (baseline) and week 2 ]
    Minimum observed concentration in plasma

  6. Pharmacokinetics-AUC [ Time Frame: Week 0 (baseline) and week 2 ]
    Area under the plasma concentration - time curve

  7. Pharmacokinetics-Tmax [ Time Frame: Week 0 (baseline) and week 2 ]
    Time to reach Cmax

  8. Pharmacokinetics - t 1/2 [ Time Frame: Week 0 (baseline) and week 2 ]
    Terminal half-life (t1/2)

  9. Pharmacokinetics-Vz/f [ Time Frame: Week 0 (baseline) and week 2 ]
    Apparent volume of distribution

  10. Pharmacokinetics-CL/F [ Time Frame: Week 0 (baseline) and week 2 ]
    Apparent total body clearance



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203943


  Show 22 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: William Smith, MD Celgene Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01203943     History of Changes
Other Study ID Numbers: CC-930-IPF-001
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by Celgene ( Celgene Corporation ):
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Fibrosis
Interstitial Lung Disease
Lung Diseases, Interstitial
CC-930

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