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Kinase Inhibitor

Selpercatinib for Cancer in Children (LIBRETTO-121 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Loxo Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

Ability to receive study drug therapy orally or via gastric access

Evidence of an activating RET gene alteration in the tumor and/or blood

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

LIBRETTO-121 Trial Summary

This trial is testing a new drug for children with cancer who have a specific genetic mutation.

Who is the study for?

This trial is for children with advanced solid tumors or brain tumors that have a specific genetic change called RET alteration. They must be stable, able to take oral medication, and not pregnant. Participants need functioning major organs and haven't had recent surgery or uncontrolled diseases.Check my eligibility

What is being tested?

The study tests LOXO-292 (Selpercatinib), an oral medication for pediatric patients with certain types of thyroid cancer, soft tissue sarcoma, and other related conditions. It's designed to see how well it works in those who've tried standard treatments without success.See study design

What are the potential side effects?

While the exact side effects aren't listed here, similar medications can cause liver issues, high blood pressure, bleeding problems, heart rhythm changes, allergic reactions and may affect growth in children.

LIBRETTO-121 Trial Eligibility Criteria

Inclusion Criteria

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

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I can take medication by mouth or through a tube in my stomach.

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My cancer has a RET gene mutation.

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My cancer has spread and does not respond to standard treatments anymore.

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I can do most activities but may need help.

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I have a stable brain tumor or metastases and haven't needed more steroids in the past week.

LIBRETTO-121 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ORR Based on Response Assessment in Neuro-Oncology (RANO) per IRC

Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Independent Review Committee (IRC)

To Determine the Safety of Oral LOXO-292 in Pediatric Participants with Advanced Solid Tumors: Dose Limiting Toxicities (DLTs)

+1 more

Secondary outcome measures

Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LOXO-292

Changes from Baseline in Health Related Quality of Life Measures as Measured by Pediatric Quality of Life (PedsQoL) Inventory Core. PedsQoL includes a list of problems with scores of 0 being 'never a problem' and 4 being 'almost always a problem'.

Changes from Baseline in Pain Measures as Measured by Wong Baker Faces scales. Wong-Baker Faces Pain Scale includes pictures of facial expressions with correlating scores of 0 being 'no hurt' and 10 being 'hurts worst'.

+20 more

LIBRETTO-121 Trial Design

1Treatment groups

Experimental Treatment

Group I: LOXO-292Experimental Treatment1 Intervention

Phase 1- Dose Escalation and determination of MTD; multiple dose levels of LOXO-292 to be evaluated; Phase 2 - The MTD/recommended dose from Phase 1

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor

66 Previous Clinical Trials

9,819 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,620 Previous Clinical Trials

3,216,549 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,695 Total Patients Enrolled

Media Library

LOXO-292 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03899792 — Phase 1 & 2

Thyroid Cancer Research Study Groups: LOXO-292

Thyroid Cancer Clinical Trial 2023: LOXO-292 Highlights & Side Effects. Trial Name: NCT03899792 — Phase 1 & 2

LOXO-292 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03899792 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this research?

"Eli Lilly and Company, the study sponsor, has determined that during the first 28-day cycle of LOXO-292 treatment period, the primary outcome to be assessed will be determining its safety on pediatric participants with Primary CNS Tumors: DLTs. Furthermore secondary measures such as Clinical Benefit Rate (by Investigator), Surgical Margin Status in Participants treated by LOXO-292 according to International Cancer Control (UICC)-R classification and Intergroup Rhabdomyosarcoma Staging (IRS) systems, as well as Descriptive Analysis of Post-Treatment Plans for Phase 2 will also evaluated"

Answered by AI

How many physical sites are offering participation in this study?

"Numerous medical centres are participating in this clinical trial, including Nemours Children's Health in Orlando, Lucile Packard Children's Hospital in Palo Alto and Texas childrens hospital in Houston. 16 sites have been selected to take part overall."

Answered by AI

What indications does LOXO-292 usually target?

"LOXO-292 is a highly effective treatment for medullary carcinoma of the thyroid, as well as other systemic illnesses such as adrenal medulla and radioactive iodine refractory."

Answered by AI

Is this experiment still recruiting participants?

"The information on clinicaltrials.gov states that this medical trial is currently enlisting participants. This study was first published on June 13th 2019 and was recently updated October 17th 2022."

Answered by AI

Is the target demographic for this experiment limited to those over thirty years of age?

"Those who meet the criteria and are between 6 months and 21 years old may apply for this trial. 184 studies were conducted with patients under 18, while 579 studies have been done to assess people 65 or older."

Answered by AI

Is it possible for me to join this research program?

"Eligibility for this trial necessitates that one has a diagnosis of soft tissue sarcoma (STS) and falls between the age bracket of 6 months to 21 years old. Approximately 100 participants are required in order to complete recruitment."

Answered by AI

Are there any antecedent investigations utilizing LOXO-292?

"Currently, LOXO-292 is the subject of 11 medical studies. Of those trials, three are in their final stages and have been launched at 1576 sites primarily in Siena, SI."

Answered by AI

Is this trial pioneering a new treatment?

"To date, 11 active trials for LOXO-292 have been conducted across 584 cities and 34 nations. The original trial was launched in 2017 under the sponsorship of Eli Lilly & Co., involving 875 patients who completed its Phase 1&2 drug approval stage. Since then, 3 additional studies have taken place."

Answered by AI

How many participants are being enrolled in this investigation?

"This clinical trial necessitates 100 compliant participants. Patients can take part from either Nemours Children's Health in Orlando, Florida or Lucile Packard Children's Hospital of Palo Alto, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

2019. "A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03899792.

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