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)

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) - CLDK378A2112

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43595

Enrollment

Registered

2015-06-30

Start date

2015-11-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non small cell lung cancer

Interventions

Treatment with ceritinib.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Steady state PK parameters.	—

Secondary

Measure	Time frame
Adverse events. ORR, DOR, DCR, TTR, PFS, OS. Single dose PK.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)