Study on Oral LOXO-292 (Selpercatinib) for Children with Advanced Solid or Brain Tumors

Sponsor: Loxo Oncology, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03899792

Provider View

This clinical trial is testing a new oral medication, LOXO-292, in children with advanced solid tumors or primary brain tumors that have a specific genetic change called RET alteration. The study aims to find the best dose and assess the treatment's effectiveness.

Patient Parameters

Program Overview

This study is exploring the use of an oral medication called LOXO-292 in children with advanced solid tumors or primary brain tumors that have a specific genetic change known as RET alteration. The study is divided into two parts: Phase 1, which focuses on finding the right dose, and Phase 2, which looks at how well the treatment works. Children will receive the medication in cycles of 28 days, and the dose will be adjusted based on their response and tolerance.

Description

The study consists of two phases. In Phase 1, researchers will determine the safest and most effective dose of LOXO-292 for children by gradually increasing the dose until they find the maximum amount that can be tolerated without significant side effects. This phase uses a 'rolling 6' method, meaning that up to six children can be enrolled at each dose level. The starting dose is based on the recommended dose for adults, which is 160 mg taken twice a day.

Once the best dose is identified, the study will move to Phase 2, where more children will receive LOXO-292 to see how well it works against different types of tumors. Children will be grouped into four different categories based on the type of tumor and its genetic characteristics. Each treatment cycle lasts 28 days, during which the child's health and response to the medication will be closely monitored.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced or metastatic solid tumor or primary brain tumor that has not responded to standard treatments.
  • Have a genetic change in the RET gene, confirmed by tests on the tumor or blood.
  • Have either measurable or non-measurable disease.
  • Have a performance score of at least 50, which indicates the ability to carry out daily activities with some help.
  • If the child has brain tumors or cancer spread to the brain, they must be stable for at least 7 days and not need increasing doses of steroids.
  • Have good blood, liver, and kidney function.
  • Be able to take the study medication by mouth or through a feeding tube.
  • Agree to use effective birth control if they are of reproductive age.

Exclusion Criteria

  • Have had major surgery within two weeks before starting the study medication.
  • Have significant heart problems or a heart attack within the last 6 months.
  • Have an active, uncontrolled infection.
  • Have a condition that affects the absorption of nutrients from food.
  • Be pregnant or breastfeeding.
  • Have uncontrolled thyroid problems that required a change in medication within the last 7 days.
  • Have uncontrolled high or low calcium levels in the blood.
  • Be allergic to LOXO-292 or any of its components.
  • Have previously been treated with a selective RET inhibitor.

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