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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

Must not have

Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension

Clinically significant active malabsorption syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

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

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I am not allergic to LOXO-292 or its liquid form ingredients.

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I have a severe nutrient absorption problem.

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I do not have any ongoing serious infections.

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I have been treated with a medication specifically targeting the RET gene.

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I have not had major surgery within the last two weeks.

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I have uncontrolled high or low calcium levels causing symptoms.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

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Secondary study objectives

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'.

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