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
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: 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
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Idiopathic Interstitial Pneumonias
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014