13 Participants Needed

Selpercatinib for Thyroid Cancer

(RAISE Trial)

SB
JR
Overseen ByJames Robinson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take strong CYP3A4 inducers or inhibitors starting 14 days before the trial and during the study. Also, you should avoid medications that cause QTc prolongation.

Is selpercatinib safe for humans?

Selpercatinib has been shown to have an acceptable safety profile in clinical trials, with common side effects including high blood pressure, liver enzyme changes, and other manageable reactions. Serious warnings include potential liver damage, high blood pressure, heart rhythm changes, bleeding, allergic reactions, and risks to unborn babies.12345

What makes the drug Selpercatinib unique for treating thyroid cancer?

Selpercatinib is unique because it is a highly selective RET kinase inhibitor specifically targeting RET alterations, which are genetic changes found in some thyroid cancers. This drug is designed to be more precise in its action compared to other treatments, potentially leading to better outcomes for patients with RET fusion-positive thyroid cancer.13678

What data supports the effectiveness of the drug Selpercatinib for thyroid cancer?

Selpercatinib has been shown to be effective in treating advanced RET fusion-positive thyroid cancer, as demonstrated in the phase I/II LIBRETTO-001 trial, which led to its approval by the US FDA. It has also shown promising results in other RET fusion-positive cancers, indicating its potential as a targeted therapy.13678

Who Is on the Research Team?

Theodore W. Laetsch, MD | Children's ...

Theodore W. Laetsch

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Agreement to use contraception during treatment
I am between 2 and 21 years old.
I can do most activities but need help with some.
See 6 more

Exclusion Criteria

I have not had any systemic treatment for thyroid cancer.
I am not pregnant or breastfeeding.
I am not taking any strong drugs that affect liver enzyme activity.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Selpercatinib Treatment

Participants receive selpercatinib monotherapy for 6 months at the FDA-approved dose

6 months

131I Therapy

Participants receive 131I therapy after 6 months of selpercatinib treatment

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • 131I Therapy
  • Selpercatinib
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Experimental: Selpercatinib Monotherapy with 131I TherapyExperimental Treatment2 Interventions

Selpercatinib is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as RETEVMO for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as RETEVMO for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Selpercatinib demonstrated a clinically meaningful objective response rate of 43.9% in patients with RET fusion-positive advanced solid tumors, indicating its efficacy in a diverse, tumor-agnostic population of 45 patients enrolled in the LIBRETTO-001 trial.
The safety profile of selpercatinib was consistent with previous studies, with common grade 3 or worse adverse events including hypertension and liver enzyme increases, but no treatment-related deaths were reported, highlighting its relative safety for patients.
Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial.Subbiah, V., Wolf, J., Konda, B., et al.[2022]
Selpercatinib (RETEVMOโ„ข) is a targeted therapy that inhibits the RET receptor tyrosine kinase, specifically designed for cancers with RET alterations.
It received FDA approval based on the promising results from the phase I/II LIBRETTO-001 trial for treating RET fusion-positive non-small-cell lung cancer, RET fusion-positive thyroid cancer, and RET-mutant medullary thyroid cancer.
Selpercatinib: First Approval.Markham, A.[2021]
Selpercatinib is an effective oral treatment for advanced RET fusion-positive non-small cell lung cancer (NSCLC), showing strong and lasting responses in both previously treated and treatment-naรฏve patients during a pivotal phase 1/2 clinical trial.
The drug has a manageable safety profile, with most adverse events being manageable through dose adjustments, and only a small number of patients discontinuing treatment due to side effects, which primarily included hypertension and elevated liver enzymes.
Selpercatinib: A Review in Advanced RET Fusion-Positive NSCLC.Nie, T., Syed, YY.[2023]

Citations

Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. [2022]
Selpercatinib: First Approval. [2021]
Selpercatinib: A Review in Advanced RET Fusion-Positive NSCLC. [2023]
Efficacy and safety of selpercatinib in Chinese patients with advanced RET-altered thyroid cancers: results from the phase II LIBRETTO-321 study. [2022]
Phase 3 Trial of Selpercatinib in Advanced RET-Mutant Medullary Thyroid Cancer. [2023]
FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions. [2022]
Selpercatinib for lung and thyroid cancers with RET gene mutations or fusions. [2021]
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors. [2023]
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