This is a Study of Eribulin Mesylate in Pediatric Patients With Recurrent or Refractory Solid Tumors (Excluding CNS) Including Lymphomas
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- STATUS
- Not Recruiting
Summary
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.
Description
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.
Details
| Condition | Lymphoma |
|---|---|
| Age | 1years - 17years |
| Clinical Study Identifier | TX4087 |
| Last Modified on | 19 February 2024 |
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