← Back to Search

Tyrosine Kinase Inhibitor

Selpercatinib for Thyroid Cancer (RAISE Trial)

Phase 2

Recruiting

Led By Theodore Laetsch, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 2-21 years, inclusive

Lansky/Karnofsky performance status >50%

Must not have

No prior systemic therapy for thyroid cancer, including RET inhibitors or 131I

Pregnant or breastfeeding females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at a new treatment option for patients with advanced papillary thyroid cancer after surgery. The current treatment, radioactive iodine therapy, is not always effective and has potential risks such as lung

Who is the study for?

This trial is for young patients aged 2-21 with advanced differentiated thyroid cancer post-surgery, who have multiple lung nodules or enlarging ones consistent with metastatic disease. They must have a RET gene alteration and good organ function, including blood counts and liver/kidney performance.

What is being tested?

The study tests Selpercatinib monotherapy before traditional radioactive iodine (RAI) therapy in pediatric thyroid cancer patients. It aims to see if pre-treatment with Selpercatinib can improve responses to RAI, which has limited effectiveness on its own.

What are the potential side effects?

Selpercatinib may cause high blood pressure, increased liver enzymes, dry mouth, diarrhea, rash or fatigue. Radioactive iodine therapy risks include pulmonary fibrosis and potential secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 2 and 21 years old.

Select...

I can do most activities but need help with some.

Select...

I had thyroid cancer, underwent thyroid removal, and received treatment for cancer spread in my neck.

Select...

My cancer has an activating RET gene change.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had any systemic treatment for thyroid cancer.

Select...

I am not pregnant or breastfeeding.

Select...

I am not taking any strong drugs that affect liver enzyme activity.

Select...

I haven't had a heart attack or significant heart disease in the last 6 months.

Select...

I have a condition that affects how my body absorbs nutrients.

Select...

I am taking medication that can affect my heart's rhythm.

Select...

I am currently experiencing significant bleeding or at high risk for serious bleeding.

Select...

My blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Number of patients who survive without progression of disease after 5 years following protocol treatment.

Number of patients with complete overall, pulmonary, structural, and biochemical response.

Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy.

+1 more

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: Experimental: Selpercatinib Monotherapy with 131I TherapyExperimental Treatment2 Interventions

Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose. Patients will receive 131I therapy after 6 months of selpercatinib. Selpercatinib will be continued for 5 days after RAI therapy and then patients will enter a wait and see period off treatment. Patients who experience disease progression at any point while on selpercatinib will proceed to 131I therapy and discontinue selpercatinib.

0 / 12Eligibility criteria met