drugset / Trial / NCT03245450
Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2018-03-05
- Primary completion
- 2021-05-17
- Completion
- 2021-05-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |