A multi-center, randomized open label study to assess the systemic exposure, efficacy, 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) (CLDK378A2112)

Phase 2

Completed

• Conditions: non small cell lung cancer; lung cancer; 10038666; 10029107

• Registration Number: NL-OMON43595
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

* Female and male patients * 18 years of age.
* Stage IIIB or IV ALK-positive NSCLC. Pre-treated and treatment-naive. See protocol page 14 for details.
* Clinically and neurologically stable CNS metastases who have not required increasing doses of steroids within 2 weeks prior to study entry to manage CNS symptoms are eligible.
* Prior treatment with ceritinib is allowed (washout at least 7 days). Prior treatment with all other ALK-inhibitors is excluded.
* Pre-treatment with chemotherapy, biologicals, investigational drugs is allowed (washout at least 2 weeks).
* WHO performance status 0 or 1 or 2.
* Measurable disease for treatment-naive subjects. See protocol page 15 for details.
* For treatment-naive subjects (neo)adjuvant treatment (excl. a regimen with an ALK-inhibitor) is allowed only if a relapse occurred more than 12 months after the end of this treatment.

Exclusion Criteria

* Prior treatment with ALK-inhibitor other than crizotinib.
* History of carcinomatous meningitis.
* Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months). See protocol page 16 for details.
* (History of) interstitial lung disease or interstitial pneumonitis (incl. radiation pneumonitis), affecting activities of daily living or requiring therapeutic intervention.
* Impairment of GI function or GI disease that may significantly alter the absorption of ceritinib
* Comedications/cotreatments etc. listed on page 16-17 of the protocol (items 10-16).
* Pregnancy, lactation, inadequate contraception (males and females). See protocol page 17-18 for details.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Steady state PK parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events. ORR, DOR, DCR, TTR, PFS, OS. Single dose PK.</p><br>