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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)

NCT02299505

Description:

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)

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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: 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)

Clinical Trial IDs

  • ORG STUDY ID: CLDK378A2112
  • NCT ID: NCT02299505

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
ceritinibceritinib 450 mg with a low-fat meal

Purpose

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)

Trial Arms

NameTypeDescriptionInterventions
ceritinib 450 mg with a low-fat mealExperimental
  • ceritinib
ceritinib 600 mg with a low-fat mealExperimental
  • ceritinib
ceritinib 750 mg on an empty stomachActive Comparator
  • ceritinib

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Plasma concentration of ceritinib
Time Frame:Study Day 22
Safety Issue:
Description:Pharmacokinetics (P)K parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description:Gastrointestinal (GI) Adverse Events (AEs), all Serious Advers Events (AEs), vital signs, electrocardiograms (ECGs) and laboratory abnormalities
Measure:Plasma concentration of ceritinib
Time Frame:Study Day 1
Safety Issue:
Description:PK parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
Measure:Objective response rate (ORR)
Time Frame:Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.
Safety Issue:
Description:Recist v1.1; Cycle = 21 days
Measure:Duration of response (DOR)
Time Frame:Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.
Safety Issue:
Description:Recist v1.1

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • LDK378
  • ceritinib
  • Alk+
  • Alk positive
  • NSCLC
  • lung Cancer

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