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Study Summary
This trial will provide continued lorlatinib treatment and safety monitoring to those who benefit from it, to further understand its safety profile.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 trial • 29 Patients • NCT03542305Trial Design
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Who is running the clinical trial?
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- My bone marrow, liver, kidneys, and pancreas are functioning well.I am not pregnant or breastfeeding.You are currently receiving a treatment called lorlatinib in another study sponsored by Pfizer and it is helping you.
- Group 1: Lorlatinib
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What is the capacity of this experiment in terms of participants?
"Affirmative. Clinicaltrials.gov displays that this medical trial, which appeared on December 28th 2021 remains active and is currently recruiting participants. 200 individuals are being enrolled from a single medical centre."
Could you please elucidate the potential risks associated with Lorlatinib?
"Lorlatinib has already been approved by the FDA, so its safety level is rated a 3."
Is this clinical research program currently enrolling participants?
"According to information hosted on clinicaltrials.gov, enrollment is presently ongoing for this medical trial which was first publicized on December 28th 2021 and last revised on February 22nd 2023."
Does this clinical research represent a pioneering effort?
"Presently, 17 trials for Lorlatinib are being conducted in 440 cities and 26 nations. The pioneer investigation of this drug occurred in 2016 when Amgen sponsored a trial with 1550 participants which eventually culminated in Phase 2 FDA clearance. Since then, 12 such studies have been completed."
Has any other experimentation been done with Lorlatinib?
"Currently, there are 17 ongoing lorlatinib clinical trials with 1 in the third stage of testing. Broadly based out of Boston, Massachusetts these tests can be found at 901 different medical sites around the world."
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