← Back to Search

Tyrosine Kinase Inhibitor

Selpercatinib for Solid Tumors and Lymphomas

Phase 2
Waitlist Available
Led By Andrea T Franson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
Must not have
Patients who have an uncontrolled infection
Patients who are currently receiving drugs that are moderate or strong inducers or inhibitors of CYP3A4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initiation of subprotocol (apec1621n) treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for children and young adults up to 21 years old with advanced solid tumors, lymphomas, or histiocytic disorders that have specific RET gene changes. They must be in good physical condition with adequate organ function and not have been treated with selpercatinib before. Pregnant or breastfeeding individuals, those who've had major surgery recently, or are on certain medications affecting the immune system can't participate.
What is being tested?
The trial is testing selpercatinib's effectiveness on patients whose cancer has spread and have alterations in the RET gene—a key driver of tumor growth. It involves imaging tests like CT scans, MRIs, PET scans, and X-rays to monitor response to treatment.
What are the potential side effects?
Selpercatinib may cause side effects such as liver issues (elevated enzymes), high blood pressure, dry mouth or altered taste sensation; it could also affect heart rhythm (QTc prolongation) which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 21 years old.
Select...
My bilirubin levels are within the normal range for my age.
Select...
I have never taken selpercatinib or similar medications for my condition.
Select...
My kidney function, measured by creatinine clearance or GFR, is normal or above.
Select...
I am mostly able to care for myself and carry on normal activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any infections that are currently uncontrolled.
Select...
I am not taking drugs that strongly affect liver enzyme CYP3A4.
Select...
I have not had major surgery in the last 14 days.
Select...
I have untreated and symptomatic thyroid issues.
Select...
I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.
Select...
I have uncontrolled high or low calcium levels causing symptoms.
Select...
I do not have conditions that affect how my body absorbs medication.
Select...
My blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initiation of subprotocol (apec1621n) treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of subprotocol (apec1621n) treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (complete response + partial response) in pediatric patients treated with selpercatinib (LOXO-292)
Secondary study objectives
Percentage of patients experiencing grade 3 or 4 adverse events
Progression-free survival (PFS)
Other study objectives
Neoplasms

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (selpercatinib)Experimental Treatment6 Interventions
Patients receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200
Radionuclide Imaging
2004
Completed Phase 2
~50
Selpercatinib
2021
Completed Phase 1
~600

Find a Location

Who is running the clinical trial?

Children's Oncology GroupNETWORK
457 Previous Clinical Trials
239,781 Total Patients Enrolled
30 Trials studying Osteosarcoma
7,805 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,788 Total Patients Enrolled
104 Trials studying Osteosarcoma
16,579 Patients Enrolled for Osteosarcoma
Andrea T FransonPrincipal InvestigatorChildren's Oncology Group

Media Library

Selpercatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04320888 — Phase 2
Osteosarcoma Research Study Groups: Treatment (selpercatinib)
Osteosarcoma Clinical Trial 2023: Selpercatinib Highlights & Side Effects. Trial Name: NCT04320888 — Phase 2
Selpercatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04320888 — Phase 2
~11 spots leftby Oct 2025