Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

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)

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)

Keywords

Non-Small Cell Lung Cancer LDK378 ceritinib Alk+ Alk positive NSCLC lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung ceritinib 750 mg on an empty stomach

Eligibility

For people ages 18 years and up

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.
  4. 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).
  5. 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.

Locations

  • Olive View UCLA Education and Research Institute SC
    Sylmar California 91342 United States
  • Pacific Shores Medical Group SC
    Long Beach California 90813 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02299505
Phase
Phase 1
Study Type
Interventional
Last Updated