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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03245450
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 5, 2018
Completion date May 17, 2021

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