This study is currently not recruiting participants.

This is a Study of Eribulin Mesylate in Pediatric Patients With Recurrent or Refractory Solid Tumors (Excluding CNS) Including Lymphomas

Study of Investigational Medication in Pediatric Patients with Recurrent or Refractory Solid Tumors

Not Recruiting
1 years - 17 years
All
Phase N/A

Brief description of study.

This is a Phase 1 study of eribulin mesylate in pediatric patients with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the MTD and/or the RP2D of this regimen in Part A1 (patients greater than or equal to 12 months and less than 18 years). Part A2 will enroll infants (greater than 6 months and less than 12 months) one dose level behind the dose level at which patients in Part A1 are enrolling, in order to maximize safety for infant subjects. Additionally, this study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate will also be described.

Detailed description of study

This is a Phase 1 study of eribulin mesylate in pediatric patients with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the MTD and/or the RP2D of this regimen in Part A1 (patients greater than or equal to 12 months and less than 18 years). Part A2 will enroll infants (greater than 6 months and less than 12 months) one dose level behind the dose level at which patients in Part A1 are enrolling, in order to maximize safety for infant subjects. Additionally, this study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate will also be described.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphoma
  • Age: 1 years - 17 years
  • Gender: All

This study investigates the effects of an investigational medication in children with recurrent or refractory solid tumors, excluding those affecting the central nervous system (CNS). The purpose is to find the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) for different age groups. The study also aims to understand how the body processes the medication and to observe any side effects.

Participants will receive the investigational medication through an intravenous (IV) line on specific days of a 21-day cycle. Researchers will monitor the levels of the medication in the body and any side effects that occur. The study will also look at how the medication affects the tumors.

  • Who can participate: Children aged 6 months to less than 18 years with recurrent or refractory solid tumors, excluding CNS tumors, may participate. The study includes two parts: Part A1 for children 12 months to less than 18 years, and Part A2 for infants 6 to 12 months.
  • Study details: Participants will receive the investigational medication intravenously once a day on Days 1 and 8 of a 21-day cycle. Researchers will monitor the medication's effects on the body and any side effects. A placebo is not used in this study.
Updated on 19 Feb 2024. Study ID: 1407659519 (PHO-COG-CROOP

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