Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors

Sponsor
Eisai Inc.
Study ID
NCT03245450
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Ewing Sarcoma
  • Non-Rhabdomyosarcoma Soft Tissue Sarcoma
  • Refractory or Recurrent Solid Tumors
  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
6 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory solid tumors (excluding central nervous system \[CNS\] tumors). The Phase 2 part of the study is conducted to assess the objective response rate (ORR) and duration of response (DOR) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and ewing sarcoma (EWS).

Key Dates

Start date
Mar 5, 2018
Status verified
Jun 2021
Primary completion
May 17, 2021
Completion
May 17, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Eribulin mesilate plus irinotecan hydrochloride
    In Schedules A and B, eribulin mesilate at the dose of 1.4 milligrams per meters squared (mg/m\^2) will be administered as an intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle. In Schedule A, irinotecan hydrochloride at the doses of 20 mg/m\^2 or 40 mg/m\^2 will be administered as an IV infusion on Days 1 to 5 of a 21-day cycle. In Schedule B, irinotecan hydrochloride at the doses of 100 mg/m\^2 or 125 mg/m\^2 will be administered as an IV infusion on Days 1 and 8 of a 21-day cycle.

Primary Outcome Measure

Phase 1: Recommended Phase 2 Dose (RP2D) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride [ Time Frame: First dose of study drug up to Cycle 1 (Cycle length=21 days) ]

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