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Selpercatinib for Solid Tumors and Lymphomas
Study Summary
This trial will test how well selpercatinib works in treating patients with advanced solid tumors, lymphomas, or histiocytic disorders that have activating RET gene alterations.
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.Trial Design
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Who is running the clinical trial?
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- I do not have any infections that are currently uncontrolled.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.I am not taking drugs that strongly affect liver enzyme CYP3A4.I have recovered from side effects of my previous cancer treatments.I was assigned a treatment in the APEC1621SC study due to a specific mutation.You have enough infection-fighting white blood cells in your body.My platelet count is at least 100,000/mm^3 without transfusions for 7 days.I have not had major surgery in the last 14 days.I am between 12 and 21 years old.My bilirubin levels are within the normal range for my age.I have never taken selpercatinib or similar medications for my condition.My cancer can be seen on scans, or if I have neuroblastoma, it shows up on special MIBG scans.My kidney function, measured by creatinine clearance or GFR, is normal or above.Your heart's QTc interval is less than or equal to 480 milliseconds.You are currently taking other medications to treat cancer.I have untreated and symptomatic thyroid issues.I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.I have uncontrolled high or low calcium levels causing symptoms.You are allergic to any parts of the experimental drug LOXO 292.I am mostly able to care for myself and carry on normal activities.I do not have conditions that affect how my body absorbs medication.My blood pressure is not controlled by medication.You have had an organ transplant in the past.Your blood protein level (serum albumin) is at least 2 grams per deciliter.Your SGPT (ALT) level in the blood should be 135 U/L or lower.
- Group 1: Treatment (selpercatinib)
- 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
What are the risks associated with taking Selpercatinib?
"Selpercatinib's safety is based on limited data from Phase 2 trials. There is no data currently supporting its efficacy."
How many total participants are allowed in this experiment?
"In order to move forward, this clinical study requires 49 participants that fit the pre-specified inclusion criteria. Potential patients can inquire about enrollment at University of Texas Health Science Center at San Antonio or Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center."
To the best of your knowledge, is this research study an innovator in its field?
"Selpercatinib has been under investigation since 2017, when the pharmaceutical company Eli Lilly and Company first sponsored a clinical trial. After the initial study involving 875 patients in 2017, Selpercatinib received Phase 1 & 2 drug approval. There are currently 11 live studies for Selpercatinib being conducted across 584 cities and 34 countries."
If I meet the requirements, am I eligible to participate in this research project?
"This study is seeking 49 individuals aged 12 months to 21 years old that have been diagnosed with Wilms Tumor. Priority will be given to applicants who meet the following additional requirements: They must have enrolled in APEC1621SC and received treatment assignment for MATCH, they must have measurable disease, they should not have previously radiated lesions, and finally they must have recovered from any prior anti-cancer therapy."
Are we still enrolling patients in this clinical trial?
"The latest information on clinicaltrials.gov suggests that this trial is still looking for patients. The posting went up on September 14th 2020 and was updated as recently as November 1st, 2022."
How has Selpercatinib been helping patients?
"Selpercatinib is most often used to treat medullary carcinoma of the thyroid, however it can also be taken as a form of therapy for other conditions like adrenal medulla and radioactive iodine-refractory."
If this study is successful, how many other hospitals could adopt the treatment?
"This clinical trial is presently enrolling patients at 100 sites. The sites are located in San Antonio, Denver and Honolulu as well as 100 other locations. It is helpful to select the site closest you to minimize travel demands if you enroll."
Are there previous studies that suggest Selpercatinib is effective?
"Selpercatinib was first researched in 2017 at Severance Hospital. In the years since, 12 clinical trials have completed with selpercatinib. As of now, there are 11 ongoing studies that are actively recruiting patients; a majority of these trials taking place in San Antonio, Texas."
Does age limit one's ability to participate in this research?
"The target age group for this research is 12 months to 21 years old. Out of 1113 medical studies, this is the only one that focuses on this specific age range. 5152 other trials exist for patients outside of this demographic."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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