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

This study has been terminated.
(The benefit/ risk profile does not support continuation of this study.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01203943
First received: September 15, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Safety [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Secondary Outcome Measures:
  • Long-term safety [ Time Frame: Weeks 52-104 ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Disease progression/death rates [ Time Frame: Up to week 56 ] [ Designated as safety issue: Yes ]
    Time to disease progression and death

  • Disease progression/death rates [ Time Frame: Weeks 52-104 ] [ Designated as safety issue: Yes ]
    Time to disease progression and death from week 52

  • Pharmacokinetics-Cmax [ Time Frame: Week 1 (baseline) and week 2 ] [ Designated as safety issue: No ]
    Maximum observed concentration in plasma

  • Pharmacokinetics-Cmin [ Time Frame: Week 0 (baseline) and week 2 ] [ Designated as safety issue: No ]
    Minimum observed concentration in plasma

  • Pharmacokinetics-AUC [ Time Frame: Week 0 (baseline) and week 2 ] [ Designated as safety issue: No ]
    Area under the plasma concentration - time curve

  • Pharmacokinetics-Tmax [ Time Frame: Week 0 (baseline) and week 2 ] [ Designated as safety issue: No ]
    Time to reach Cmax

  • Pharmacokinetics - t 1/2 [ Time Frame: Week 0 (baseline) and week 2 ] [ Designated as safety issue: No ]
    Terminal half-life (t1/2)

  • Pharmacokinetics-Vz/f [ Time Frame: Week 0 (baseline) and week 2 ] [ Designated as safety issue: No ]
    Apparent volume of distribution

  • Pharmacokinetics-CL/F [ Time Frame: Week 0 (baseline) and week 2 ] [ Designated as safety issue: No ]
    Apparent total body clearance


Enrollment: 28
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203943

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

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01203943     History of Changes
Other Study ID Numbers: CC-930-IPF-001
Study First Received: September 15, 2010
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by 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
Lung Diseases, Interstitial
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias

ClinicalTrials.gov processed this record on April 23, 2014