Study of LAM561 Acid in Children with Malignant Glioma and Other Advanced Solid Tumors

Sponsor: Laminar Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04299191

Provider View

This clinical trial is testing a new drug, LAM561, in children with advanced brain tumors and other solid tumors to find a safe and effective dose.

Patient Parameters

Program Overview

This study is testing a new drug called LAM561 in children with advanced brain tumors (gliomas) and other solid tumors. The study has two parts: first, to find a safe dose by gradually increasing it in small groups of patients, and second, to test this dose in a larger group to see if it is well-tolerated. Children with different types of tumors can join the study as spots become available, and no specific tumor type is prioritized over another.

Description

Children in this study will receive a dose of LAM561 based on the group they are placed in. They will take the drug daily in 21-day cycles, which can be repeated as long as the treatment is helping and not causing unacceptable side effects. If there are significant side effects, the treatment schedule might change to allow breaks, except during the first cycle of dose testing. The dose might also be reduced or delayed if needed, but not by more than 14 days. Most children will receive between one and six cycles of treatment, lasting from 3 to 18 weeks. If the treatment is beneficial, it may continue under special conditions after the study ends.

Eligibility Criteria

Inclusion Criteria

  • Children under 18 years old.
  • Have a confirmed diagnosis of an advanced solid tumor that is not responding to standard treatments or has no standard treatment available.
  • Must start treatment within 14 days of joining the study.
  • Must have a performance status score of 50% or higher, meaning they can perform daily activities with some help.
  • Must be able to take oral medication or have a feeding tube for drug administration.
  • Must be able to undergo tumor imaging tests like CT or MRI scans.
  • Must have adequate blood, kidney, and liver function based on specific lab tests.
  • Must not have a history of heart rhythm problems and must have a normal heart rhythm at the start of the study.
  • Must not have a bleeding disorder.
  • Females of childbearing age must have a negative pregnancy test before starting treatment.
  • Must provide written consent to participate in the study.
  • Mothers must agree not to breastfeed while on the study.

Exclusion Criteria

  • Adults 18 years or older.
  • Known allergy to any part of the study drug.
  • Use of another investigational drug recently before starting LAM561.
  • Significant side effects from previous cancer treatments that could affect safety assessments.
  • Recent major surgery, except for minor procedures like shunt or line insertion.
  • Recent significant bleeding in the brain or tumor.
  • History of serious heart disease or recent heart attack.
  • Digestive issues that could affect drug absorption.
  • Unable to take oral medication due to severe vomiting.
  • Uncontrolled high cholesterol or need for cholesterol-lowering medication.
  • Severe or uncontrolled other medical conditions.
  • Need for certain medications like warfarin or phenytoin.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Pregnant females.
  • Lactating females must agree not to breastfeed.
  • Participants of reproductive age must agree to use effective birth control during and for six months after the study.

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