NCT06006273

A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

Summary

To find the recommended dose of eribulin that can be given in combination with irinotecan and temozolomide to treat relapsed and/or refractory solid tumors.

Detailed description

Primary Objectives: * To determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of eribulin in combination with fixed doses of irinotecan and temozolomide. * To determine the safety and tolerance of Eribulin when given in conjunction with Irinotecan and Temozolamide (IT) in children with refractory and relapsed (R/R) solid tumors. Secondary Objectives: --To observe and record disease response (anti-tumor activity). Although the clinical benefit of Eribulin when given together with Irinotecan and Temozolamide has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief. Outcomes for disease response include Best Overall Response (BOR), Duration of Response (DOR), and Progression-Free Survival (PFS).

Conditions

• Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	Eribulin	Given by vein (IV)
DRUG	Irinotecan	Given by vein (IV)
DRUG	Temozolomide	Given by PO

Timeline

• Start date: 2023-08-16
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2023-08-23
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study