NCT03245450

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

A Phase 1/2 Single-arm Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan in Children With Refractory or Recurrent Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 6 Months – 25 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Eribulin mesilate	IV infusion
DRUG	Irinotecan hydrochloride	IV infusion

Timeline

• Start date: 2018-03-05
• Primary completion: 2021-05-17
• Completion: 2021-05-17
• First posted: 2017-08-10
• Last updated: 2022-06-28
• Results posted: 2022-06-28

Locations

39 sites across 8 countries: France, Germany, Greece, Italy, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study