Study on Ensartinib for Treating Relapsed or Hard-to-Treat Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders with ALK or ROS1 Changes in Children and Young Adults

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03213652

Provider View

This clinical trial is testing the effectiveness of ensartinib, a drug that may help stop tumor growth, in children and young adults with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific genetic changes and have not responded to previous treatments or have returned.

Patient Parameters

Program Overview

This study is exploring how well the drug ensartinib works in treating children and young adults with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific genetic changes in ALK or ROS1. These conditions have either come back after treatment or have not responded to previous treatments. Ensartinib may help stop the growth of cancer cells by blocking certain enzymes needed for cell growth. Participants will take ensartinib by mouth daily in cycles of 28 days, for up to 2 years, as long as the disease does not progress and side effects are manageable. Various scans and tests will be conducted to monitor the disease and the patient's health.

Description

The main goal of this study is to see how well ensartinib can shrink tumors in children and young adults with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific ALK or ROS1 genetic changes. Researchers will also look at how long patients can live without the disease getting worse and how well the drug is tolerated. The study will also gather information on how the body processes ensartinib and explore other genetic markers that might predict how well the drug works.

Participants will take ensartinib by mouth once a day for 28-day cycles, continuing for up to 2 years unless the disease progresses or side effects become too severe. During the study, participants will undergo various imaging tests, such as X-rays, CT scans, MRIs, and PET scans, as well as blood tests and possibly bone marrow tests, to monitor their condition and response to the treatment. After completing the treatment, participants will be followed up for 30 days to check on their health.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in a specific treatment assignment program based on having a genetic change that can be targeted by the study drug.
  • Age between 12 months and 21 years.
  • Body surface area of at least 0.5 square meters.
  • Must have measurable disease on scans, or for neuroblastoma, disease that can be evaluated by specific scans.
  • Must have a performance status score indicating they are able to carry out daily activities.
  • Must have recovered from previous cancer treatments and meet specific timeframes since last treatment.
  • Must have adequate blood counts and organ function as determined by specific tests.
  • Must be able to swallow capsules.
  • Must provide informed consent and assent if applicable.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.
  • Must not be taking certain medications, including other investigational drugs or anti-cancer agents.
  • Must not have an uncontrolled infection.
  • Must not have had a solid organ transplant.
  • Must be able to comply with study requirements and safety monitoring.

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