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Selpercatinib for Solid Tumors (LIBRETTO-001 Trial)
LIBRETTO-001 Trial Summary
This trial is designed to study the effects of a new drug, selpercatinib, on various types of solid tumors. The goal is to see if it is safe and tolerable, how it is metabolized, and if it has any preliminary anti-tumor activity.
LIBRETTO-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLIBRETTO-001 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LIBRETTO-001 Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 2 weeks.I am not taking strong drugs that affect liver enzymes or forbidden medications.I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.My lung cancer is in an early stage, operable, and has not been treated yet.I haven't had a heart attack in the last 6 months and my heart's electrical cycle is normal.My cancer does not initially need a RET gene alteration, but will require it after initial treatment.You have a disease that can be measured by specific guidelines for your type of tumor.You are expected to live for at least 3 more months.My blood, liver, and kidney functions are all within normal ranges.I stopped a RET inhibitor treatment but may join with approval.My cancer cannot be measured by standard tests.I have not had any systemic therapy for my lung cancer.My cancer has worsened despite treatment, or I can't tolerate/decline standard treatments.I have previously been treated with drugs targeting multiple kinases including RET.I can care for myself and remain up and about more than half of my waking hours.I've had targeted radiation for symptom relief recently, but not on over 30% of my bone marrow or a wide area.My brain or spinal cancer symptoms are stable, and I haven't had surgery or radiation recently.I have tried or am not suited for standard treatments for my cancer type and stage.My tumor has a RET gene alteration.My cancer is part of the MTC spectrum or has RET changes, pending approval.I have previously been treated with a RET inhibitor.I haven't taken any experimental cancer treatments recently.My cancer has a known genetic mutation driving its growth.I have at least one tumor that can be measured and hasn't been treated with radiation.You do not fit the specific requirements for participating in Cohorts 3 or 4.
- Group 1: LOXO-292
- 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
Has LOXO-292 been evaluated in other research projects?
"Currently, 11 trials researching LOXO-292 are in progress with 3 at the Phase 3 stage. These medical experiments span from Seoul to Shizuoka and across 1576 sites worldwide."
How many participants are involved in the current research?
"Confirmative. Clinicaltrials.gov data affirms that since its first posting on the 2nd of May, 2017 this research has been actively recruiting participants from 45 different medical centres in pursuit of 875 volunteers."
Is this scientific experiment the inaugural one of its type?
"LOXO-292 has been subject to 11 trials in 34 countries and 584 cities since its original study, which was sponsored by Eli Lilly & Co. commenced back in 2017. This first experiment involved 875 test subjects and completed both phases 1 & 2 of drug approval successfully. Since then, 3 additional studies have taken place."
Are there any registration opportunities for this research trial still available?
"Per data found on clinicaltrials.gov, the study is currently recruiting participants. It was first posted in May 2nd 2017 and last updated October 10th 2022."
What therapeutic purposes is LOXO-292 typically employed for?
"LOXO-292 is a medication that frequently prescribed to treat medullary carcinoma of the thyroid. Additionally, it can be used as an option for providing systemic therapy to those with radioactive iodine-refractory adrenal medulla cancer."
What objectives have been set for this study in order to achieve an optimal outcome?
"According to the Eli Lilly and Company, who are sponsoring this clinical trial, the primary endpoint measured over a 4-week period is RP2D. Furthermore, secondary outcomes such as AUC of LOXO-292 (Selpercatinib), number of participants with TRAEs, and CNS DOR by IRC will also be assessed through this investigation."
How many venues are presently managing this trial?
"This medical trial is executing out of 45 separate sites, such as Mayo Clinic-Scottsdale in Scottsdale, Hoag Memorial Hospital Presbyterian in Newport Beach and Mayo Clinic-Jacksonville. These are only a few examples from the full list."
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