Last updated on December 2019

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


Brief description of study

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 Study Identifier: NCT03245450

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Hospital Sant Joan de Deu

Esplugues De Llobregat, Spain
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The University of Birmingham

Birmingham, United Kingdom
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Addenbrooke's Hospital

Cambridge, United Kingdom
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Christie Hospital

Manchester, United Kingdom
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Royal Victoria Infirmary

Newcastle, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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Recruitment Status: Open


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