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Continued Access to Ceritinib for Cancer
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently on ceritinib in a Novartis study and my doctor thinks I should continue.I stopped taking ceritinib due to side effects that haven't gone away.I am willing and able to follow the study's schedule and procedures.I am using effective birth control and will continue for 3 months after stopping ceritinib.I am a man who will use a condom during treatment and for 3 months after, and I won't father a child during this time.
- Group 1: ceritinib
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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