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Trial record 2 of 6 for:    Celgene | IPF

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE September 15, 2010
First Posted Date  ICMJE September 17, 2010
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE January 1, 2011
Actual Primary Completion Date January 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Safety [ Time Frame: Week 4 ]
Number of participants with adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
Evaluate the type, frequency, severity, and relationship of adverse events to CC-930 (through laboratory, electrocardiogram [ECG], physical exam, change in pulmonary function tests or other changes) [ Time Frame: Up to 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • Long-term safety [ Time Frame: Weeks 52-104 ]
    Number of participants with adverse events
  • Disease progression/death rates [ Time Frame: Up to week 56 ]
    Time to disease progression and death
  • Disease progression/death rates [ Time Frame: Weeks 52-104 ]
    Time to disease progression and death from week 52
  • Pharmacokinetics-Cmax [ Time Frame: Week 1 (baseline) and week 2 ]
    Maximum observed concentration in plasma
  • Pharmacokinetics-Cmin [ Time Frame: Week 0 (baseline) and week 2 ]
    Minimum observed concentration in plasma
  • Pharmacokinetics-AUC [ Time Frame: Week 0 (baseline) and week 2 ]
    Area under the plasma concentration - time curve
  • Pharmacokinetics-Tmax [ Time Frame: Week 0 (baseline) and week 2 ]
    Time to reach Cmax
  • Pharmacokinetics - t 1/2 [ Time Frame: Week 0 (baseline) and week 2 ]
    Terminal half-life (t1/2)
  • Pharmacokinetics-Vz/f [ Time Frame: Week 0 (baseline) and week 2 ]
    Apparent volume of distribution
  • Pharmacokinetics-CL/F [ Time Frame: Week 0 (baseline) and week 2 ]
    Apparent total body clearance
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
  • Pharmacokinetics (PK) of CC-930 and metabolite M18 in plasma [ Time Frame: Baseline and Week 2 ]
  • Long-term safety [ Time Frame: Up to 56 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
Brief Summary The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Fibrosis
  • Fibrosis
  • Interstitial Lung Disease
  • Lung Diseases, Interstitial
Intervention  ICMJE
  • Drug: CC-930
    CC-930 50 mg PO daily up to 56 weeks beginning on Day 1
  • Other: Placebo
    Placebo
  • Drug: CC-930
    CC-930 100 mg PO daily up to 56 weeks 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: CC-930
  • 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
    Intervention: Drug: CC-930
  • 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.
    Intervention: Drug: CC-930
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * van der Velden JL, Ye Y, Nolin JD, Hoffman SM, Chapman DG, Lahue KG, Abdalla S, Chen P, Liu Y, Bennett B, Khalil N, Sutherland D, Smith W, Horan G, Assaf M, Horowitz Z, Chopra R, Stevens RM, Palmisano M, Janssen-Heininger YM, Schafer PH. JNK inhibition reduces lung remodeling and pulmonary fibrotic systemic markers. Clin Transl Med. 2016 Dec;5(1):36. doi: 10.1186/s40169-016-0117-2. Epub 2016 Sep 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 16, 2012)
28
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2010)
36
Actual Study Completion Date  ICMJE August 24, 2012
Actual Primary Completion Date January 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01203943
Other Study ID Numbers  ICMJE CC-930-IPF-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Smith, MD Celgene Corporation
PRS Account Celgene
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP