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Tyrosine Kinase Inhibitor

Continued Access to Ceritinib for Cancer

Phase 4

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until no patients are left on study up to 5 years

Awards & highlights

Study Summary

This trial will provide the drug ceritinib to patients who are already receiving it and who the investigator believes would benefit from continued treatment.

Who is the study for?

This trial is for patients already taking ceritinib in a Novartis study, who could benefit from continuing it. They must have followed previous study rules well and agree to future procedures. It's not for those with unresolved side effects from ceritinib, pregnant or breastfeeding women, or those not using effective birth control.Check my eligibility

What is being tested?

The trial provides ongoing access to ceritinib for cancer patients benefiting from it in prior Novartis studies. The focus is on the continued effectiveness and safety of ceritinib as a treatment option.See study design

What are the potential side effects?

Ceritinib may cause side effects such as gastrointestinal issues (like diarrhea), liver problems, fatigue, decreased appetite, and heartburn. Unresolved toxicities are reasons for exclusion from this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until no patients are left on study up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until no patients are left on study up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and until no patients are left on study up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Trial Design

1Treatment groups

Experimental Treatment

Group I: ceritinibExperimental Treatment1 Intervention

The starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent ceritinib study at the time of the rollover.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ceritinib

2015

Completed Phase 1

~890

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,098 Total Patients Enrolled

Media Library

Ceritinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02584933 — Phase 4

Cancer Clinical Trial 2023: Ceritinib Highlights & Side Effects. Trial Name: NCT02584933 — Phase 4

Ceritinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02584933 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals currently being enrolled in this research project?

"As outlined on clinicaltrials.gov, this medical experiment is currently recruiting participants; the listing was initially submitted in December 2015 and revised last November 2022."

Answered by AI

To what degree can ceritinib be relied upon to not cause adverse effects?

"Due to ceritinib's approval as a pharmaceutical treatment, its safety was assigned the highest score of 3."

Answered by AI

Have any other research studies explored the effects of ceritinib?

"Currently, 12 distinct clinical trials are exploring the effects of ceritinib with three of them in Phase 3. Of these studies, most take place in Boise, Idaho; however there is a broad range of 831 research sites that offer this medication."

Answered by AI

Has a similar medical research project ever been conducted before?

"At the moment, 12 clinical trials using ceritinib are being conducted in 465 cities and 37 nations. Novartis Pharmaceuticals was responsible for the original study which began in 2013 involving 231 participants - it has since progressed to Phase 3 drug approval. A further 17 studies have been carried out since then."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

2015. "Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02584933.

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