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

Primary Objectives: ‐ To determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) oferibulin in combination with fixed doses of irinotecan and temozolomide. ‐ To determine the safety and tolerance of Eribulin when given in conjunction withIrinotecan 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 clinicalbenefit of Eribulin when given together with Irinotecan and Temozolamide has not yet beenestablished, the intent of offering this treatment is to provide a possible therapeuticbenefit, and thus the patient will be carefully monitored for tumor response and symptomrelief. Outcomes for disease response include Best Overall Response (BOR), Duration ofResponse (DOR), and Progression‐Free Survival (PFS).