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Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT02299505
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 14, 2014
First Posted Date  ICMJE November 24, 2014
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE April 9, 2015
Actual Primary Completion Date June 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
Plasma concentration of ceritinib [ Time Frame: Study Day 22 ]
Pharmacokinetics (P)K parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • Safety profile [ Time Frame: The primary analysis will be based on data from all patients, up to the time at which all randomized patients have completed at least 12 weeks of ceritinib treatment or have discontinued study treatment, whichever is earlier. ]
    Gastrointestinal (GI) Adverse Events (AEs), all Serious Advers Events (AEs), vital signs, electrocardiograms (ECGs) and laboratory abnormalities
  • Plasma concentration of ceritinib [ Time Frame: Study Day 1 ]
    PK parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
  • Objective response rate (ORR) [ Time Frame: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease. ]
    Recist v1.1; Cycle = 21 days
  • Duration of response (DOR) [ Time Frame: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease. ]
    Recist v1.1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Multi-center, Randomized Open Label Study to Assess the Systemic Exposure, Effiacy, and Safety of 450 mg Ceritinib Taken With a Low-fat Meal and 600 mg Ceritinib Taken With a Low-fat Meal as Compared With That of 750 mg Ceritinib Taken in the Fasted State in Adult Patients With ALK Rearranged (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
Brief Summary A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: ceritinib
Study Arms  ICMJE
  • Experimental: ceritinib 450 mg with a low-fat meal
    Intervention: Drug: ceritinib
  • Experimental: ceritinib 600 mg with a low-fat meal
    Intervention: Drug: ceritinib
  • Active Comparator: ceritinib 750 mg on an empty stomach
    Intervention: Drug: ceritinib
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2019)
306
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
150
Actual Study Completion Date  ICMJE March 6, 2020
Actual Primary Completion Date June 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  1. Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.
  2. Patients may have received one prior treatment regimen with crizotinib (all other ALK inhibitors are excluded).
  3. Patients may have received prior chemotherapy, biologic therapy, or other investigational agents. ALK inhibitors other than crizotinib are excluded.
  4. Patient has a World Health Organization (WHO) performance status 0-2.

Exclusion:

  1. Prior treatment with an ALK inhibitor other than crizotinib.
  2. History of carcinomatous meningitis.
  3. Presence or history of a malignant disease other than an ALK-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.

5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) 6. Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).

7. Patient has other severe, acute, or chronic medical conditions 8. Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Czechia,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Lebanon,   Malaysia,   Netherlands,   Poland,   Russian Federation,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   France,   Hungary
 
Administrative Information
NCT Number  ICMJE NCT02299505
Other Study ID Numbers  ICMJE CLDK378A2112
2014-004001-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2020

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