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)

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT02299505
• Date of registration: 14/11/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public 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)
• Scientific 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)
• Date of first enrolment: April 9, 2015
• Target sample size: 306
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02299505
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Czechia, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Lebanon, Malaysia, Netherlands, Poland, Russian Federation, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a
candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.

- Patients may have received one prior treatment regimen with crizotinib (all other ALK
inhibitors are excluded).

- Patients may have received prior chemotherapy, biologic therapy, or other
investigational agents. ALK inhibitors other than crizotinib are excluded.

- Patient has a World Health Organization (WHO) performance status 0-2.

Exclusion Criteria:

- Prior treatment with an ALK inhibitor other than crizotinib.

- History of carcinomatous meningitis.

- 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.

- Clinically significant, uncontrolled heart disease and/or recent cardiac event (within
6 months)

- 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).

- Patient has other severe, acute, or chronic medical conditions

- Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other
coumarin-derivative anticoagulants.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: ceritinib

Primary Outcome(s)

Plasma concentration of ceritinib [Time Frame: Study Day 22]

Secondary Outcome(s)

Duration of response (DOR) [Time Frame: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.]

Objective response rate (ORR) [Time Frame: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.]

Plasma concentration of ceritinib [Time Frame: Study Day 1]

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.]

Secondary ID(s)

2014-004001-32

CLDK378A2112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors