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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 up to 2 years from study entry

Awards & highlights

No Placebo-Only Group

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

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I am between 12 and 21 years old.

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My bilirubin levels are within the normal range for my age.

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I have never taken selpercatinib or similar medications for my condition.

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My kidney function, measured by creatinine clearance or GFR, is normal or above.

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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:

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I do not have any infections that are currently uncontrolled.

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I am not taking drugs that strongly affect liver enzyme CYP3A4.

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I have not had major surgery in the last 14 days.

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I have untreated and symptomatic thyroid issues.

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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I have uncontrolled high or low calcium levels causing symptoms.

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I do not have conditions that affect how my body absorbs medication.

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My blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from study entry 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180