Non-Small Cell Lung CancerPhase 1NCT02299505
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)
A Phase 1 study testing ceritinib in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 73 sites in 24 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- ceritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 73 sitesin 24 countries
- Study dates
- 9 Apr 2015to 6 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
73 sites in 24 countries.
73 sites in 24 countries
Italy11 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Meldola, FC, 47014
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Roma, RM, 00155
Novartis Investigative Site
San Giovanni Rotondo, FG, 71013
Novartis Investigative Site
Verona, VR, 37126
United States7 sites
Essex Oncology of North Jersey PA SC
Belleville, New Jersey, 07109
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Greenville Health System SC
Greenville, South Carolina, 29615
Goshen Center for Cancer Care IU Health - SC
Indianapolis, Indiana, 46202
Loma Linda University
Loma Linda, California, 92354
Maryland Oncology Hematology, P.A. SC-2
Rockville, Maryland, 20850
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City, Utah, 84106
Brazil6 sites
Novartis Investigative Site
Barretos, São Paulo, 14784 400
Novartis Investigative Site
Itajaí, Santa Catarina, 88301-229
Novartis Investigative Site
Natal, Rio Grande do Norte, 59075 740
Novartis Investigative Site
Passo Fundo, Rio Grande do Sul, 99010-260
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90601-000
Novartis Investigative Site
São Paulo, São Paulo, 01246 000
India5 sites
Novartis Investigative Site
Bangalore, Karnataka, 560 095
Novartis Investigative Site
Delhi, 110 085
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500 034
Novartis Investigative Site
Kolkata, West Bengal, 700063
Novartis Investigative Site
Nashik, Maharashtra, 422002
Spain5 sites
Novartis Investigative Site
Donostia / San Sebastian, Basque Country, 20080
Novartis Investigative Site
Madrid, 28050
Novartis Investigative Site
Madrid, 28222
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Seville, Andalusia, 41009
Canada4 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Germany4 sites
Novartis Investigative Site
Berlin, 12351
Novartis Investigative Site
Cologne, 51109
Novartis Investigative Site
Regensburg, Bavaria, 93053
Novartis Investigative Site
Würzburg, 97074
South Korea4 sites
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 06351
Poland3 sites
Novartis Investigative Site
Gdansk, 80 952
Novartis Investigative Site
Konin, 62 500
Novartis Investigative Site
Tarnobrzeg, 39-400
Taiwan3 sites
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 110
Novartis Investigative Site
Taoyuan, 33305
Thailand3 sites
Novartis Investigative Site
Bangkok, THA, 10330
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Hat Yai, Changwat Songkhla, 90110
Australia2 sites
Novartis Investigative Site
Auckland
Novartis Investigative Site
Grafton, Auckland
Austria2 sites
Novartis Investigative Site
Vienna, 1210
Novartis Investigative Site
Vienna, A-1140
Greece2 sites
Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, GR14564
Malaysia2 sites
Novartis Investigative Site
Kuching, Sarawak, 93586
Novartis Investigative Site
Pulau Pinang, 10990
United Kingdom2 sites
Novartis Investigative Site
Metropolitan Borough of Wirral, Merseyside, CH63 4JY
Novartis Investigative Site
Newcastle upon Tyne, Newcastle, NE7 7DN
Turkey (Türkiye)1 site
Novartis Investigative Site
Talas / Kayseri, 38039
About this study
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)
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)
Read the detailed description
This was an open-label, randomized, multi-center, parallel design, Phase I study in which the systemic exposure, efficacy and safety of ceritinib administered at 450 mg or 600 mg with a low-fat meal vs 750 mg in the fasted state was assessed in subjects with ALK+ NSCLC following multiple oral daily dosing of ceritinib. Subjects were randomized in a 1:1:1 ratio to once daily doses of oral ceritinib (450 mg following a low-fat meal, 600 mg following a low-fat meal or ceritinib 750 mg administered on an empty stomach). Randomization was stratified by brain metastases at Screening (presence or absence) and by prior treatment (prior crizotinib use with ALK+ determined by Fluorescent in situ hybridization (FISH); crizotinib-naïve but could be previously treated with other systemic anti-cancer therapy with ALK+ determined by FISH, or treatment-naïve subjects with ALK+ by IHC).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- ceritinib
- Keywords
- LDK378, ceritinib, Alk+, Alk positive, NSCLC, lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceritinibDrug
Also called LDK378
The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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) Receives: Drug: ceritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of ceritinib
Pharmacokinetics (PK) parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
Measured: Study Day 22
Secondary outcomes (4)
Safety profile
Gastrointestinal (GI) Adverse Events (AEs), all Serious Advers Events (AEs), vital signs, electrocardiograms (ECGs) and laboratory abnormalities
Measured: 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
PK parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
Measured: Study Day 1
Objective response rate (ORR)
Recist v1.1; Cycle = 21 days
Measured: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.
Duration of response (DOR)
Recist v1.1
Measured: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start9 Apr 2015
- Primary completion16 Jun 2016
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299505
- Sponsor's protocol ID
- CLDK378A2112
- Other IDs
- 2014-004001-32, 2014
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2014
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02299505
- Acronym / sponsor ID
- CLDK378A2112
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- LDK378, ceritinib, Alk+, Alk positive, NSCLC, lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- 16 Jun 2016 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This was an open-label, randomized, multi-center, parallel design, Phase I study in which the systemic exposure, efficacy and safety of ceritinib administered at 450 mg or 600 mg with a low-fat meal vs 750 mg in the fasted state was assessed in subjects with ALK+ NSCLC following multiple oral daily dosing of ceritinib. Subjects were randomized in a 1:1:1 ratio to once daily doses of oral ceritinib (450 mg following a low-fat meal, 600 mg following a low-fat meal or ceritinib 750 mg administered on an empty stomach). Randomization was stratified by brain metastases at Screening (presence or absence) and by prior treatment (prior crizotinib use with ALK+ determined by Fluorescent in situ hybridization (FISH); crizotinib-naïve but could be previously treated with other systemic anti-cancer therapy with ALK+ determined by FISH, or treatment-naïve subjects with ALK+ by IHC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ceritinib 450 mg with a low-fat meal | Experimental | Drug: ceritinibOral 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. |
| ceritinib 600 mg with a low-fat meal | Experimental | Drug: ceritinibOral 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. |
| ceritinib 750 mg on an empty stomach | Active comparator | Drug: ceritinibOral 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceritinibAlso: LDK378The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration. | Drug | ceritinib 450 mg with a low-fat meal, ceritinib 600 mg with a low-fat meal, ceritinib 750 mg on an empty stomach |
Primary outcome
Plasma concentration of ceritinib
Time frame: Study Day 22
Pharmacokinetics (PK) parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
4 secondary outcomes
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.
Plasma concentration of ceritinib
Time frame: Study Day 1
Objective response rate (ORR)
Time frame: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.
Duration of response (DOR)
Time frame: Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Results for CLDK378A2112 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
73 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ceritinib in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 73 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Italy, United States, Brazil, India, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of ceritinib (time frame: Study Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.