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 | Completed Phase 1 FDA Drug

• 2 other identifiers: CLDK378A21122014-004001-32
• Study Type: interventional
• Target: 306
• Locations: 23 countries
• Sites: 71

Brief 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)

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of ceritinib

  Pharmacokinetics (PK) parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F

  Study Day 22

Secondary Outcomes (4)

• Safety profile

  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.

• Plasma concentration of ceritinib

  Study Day 1

• Objective response rate (ORR)

  Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.

• Duration of response (DOR)

  Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.

Study Arms (3)

ceritinib 450 mg with a low-fat meal

EXPERIMENTAL

Oral ceritinib QD (21 days/ cycle) at a dose of 450 mg (3×150 mg/capsule) administered in the morning immediately (within 30 minutes)following a low-fat meal.

Drug: ceritinib

ceritinib 600 mg with a low-fat meal

EXPERIMENTAL

Oral ceritinib QD (21 days/ cycle) at a dose of 600 mg (4×150 mg/capsule) administered in the morning immediately (within 30 minutes) following a low-fat meal.

Drug: ceritinib

ceritinib 750 mg on an empty stomach

ACTIVE COMPARATOR

Oral ceritinib QD (21 days/ cycle) at a dose of 750 mg (5×150 mg/capsule) administered in the morning on an empty stomach (i.e., fasted from food and drink except water)

Drug: ceritinib

Interventions

ceritinib DRUG

The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.

Also known as: LDK378

ceritinib 450 mg with a low-fat meal; ceritinib 600 mg with a low-fat meal; ceritinib 750 mg on an empty stomach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (73)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Goshen Center for Cancer Care IU Health - SC

Indianapolis, Indiana, 46202, United States

Location

Maryland Oncology Hematology, P.A. SC-2

Rockville, Maryland, 20850, United States

Location

Essex Oncology of North Jersey PA SC

Belleville, New Jersey, 07109, United States

Location

Greenville Health System SC

Greenville, South Carolina, 29615, United States

Location

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

Salt Lake City, Utah, 84106, United States

Location

Novartis Investigative Site

Grafton, Auckland, Australia

Location

Novartis Investigative Site

Auckland, Australia

Location

Novartis Investigative Site

Vienna, 1210, Austria

Location

Novartis Investigative Site

Vienna, A-1140, Austria

Location

Novartis Investigative Site

Edegem, 2650, Belgium

Location

Novartis Investigative Site

Natal, Rio Grande do Norte, 59075 740, Brazil

Location

Novartis Investigative Site

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90601-000, Brazil

Location

Novartis Investigative Site

Itajaí, Santa Catarina, 88301-229, Brazil

Location

Novartis Investigative Site

Barretos, São Paulo, 14784 400, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01246 000, Brazil

Location

Novartis Investigative Site

Sofia, 1303, Bulgaria

Location

Novartis Investigative Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8V 5C2, Canada

Location

Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

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Novartis Investigative Site

Montería, Colombia

Location

Novartis Investigative Site

Brno, 65653, Czechia

Location

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

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Novartis Investigative Site

Berlin, 12351, Germany

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Novartis Investigative Site

Cologne, 51109, Germany

Location

Novartis Investigative Site

Würzburg, 97074, Germany

Location

Novartis Investigative Site

Athens, GR, 115 27, Greece

Location

Novartis Investigative Site

Athens, GR14564, Greece

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Novartis Investigative Site

Hyderabad, Andhra Pradesh, 500 034, India

Location

Novartis Investigative Site

Bangalore, Karnataka, 560 095, India

Location

Novartis Investigative Site

Nashik, Maharashtra, 422002, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700063, India

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Novartis Investigative Site

Delhi, 110 085, India

Location

Novartis Investigative Site

Bergamo, BG, 24127, Italy

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

San Giovanni Rotondo, FG, 71013, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Aviano, PN, 33081, Italy

Location

Novartis Investigative Site

Roma, RM, 00155, Italy

Location

Novartis Investigative Site

Verona, VR, 37126, Italy

Location

Novartis Investigative Site

Novara, 28100, Italy

Location

Novartis Investigative Site

El Achrafiyé, Lebanon, 166484, Lebanon

Location

Novartis Investigative Site

Kuching, Sarawak, 93586, Malaysia

Location

Novartis Investigative Site

Pulau Pinang, 10990, Malaysia

Location

Novartis Investigative Site

Nieuwegein, 3435 CM, Netherlands

Location

Novartis Investigative Site

Gdansk, 80 952, Poland

Location

Novartis Investigative Site

Konin, 62 500, Poland

Location

Novartis Investigative Site

Tarnobrzeg, 39-400, Poland

Location

Novartis Investigative Site

Saint Petersburg, 197343, Russia

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Seoul, 06351, South Korea

Location

Novartis Investigative Site

Seville, Andalusia, 41009, Spain

Location

Novartis Investigative Site

Donostia / San Sebastian, Basque Country, 20080, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Madrid, 28050, Spain

Location

Novartis Investigative Site

Madrid, 28222, Spain

Location

Novartis Investigative Site

Taichung, 40447, Taiwan

Location

Novartis Investigative Site

Taipei, 110, Taiwan

Location

Novartis Investigative Site

Taoyuan District, 33305, Taiwan

Location

Novartis Investigative Site

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Novartis Investigative Site

Bangkok, THA, 10330, Thailand

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Talas / Kayseri, 38039, Turkey (Türkiye)

Location

Novartis Investigative Site

Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, Newcastle, NE7 7DN, United Kingdom

Location

Related Links

• Results for CLDK378A2112 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

ceritinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 24, 2014
• Study Start: April 9, 2015
• Primary Completion: June 16, 2016
• Study Completion: March 6, 2020
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); KR (4); ES (5); LE (1); BU (1); TU (1); AU (2); TW (3); BE (1); PL (3); US (7); GR (2); IN (5); CO (1); DE (4); RU (1); IT (11); TH (3); MY (2); NL (1); CA (4); BR (6); GB (2)