NCT02013336

Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: South Plains Oncology Consortium · Network
• Sex: All
• Age: 12 Months – 20 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide.

Conditions

• Recurrent or Refractory Solid Tumors
• Ewing Sarcoma
• Rhabdomyosarcoma
• Neuroblastoma
• Osteosarcoma

Interventions

Type	Name	Description
DRUG	MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide	chemotherapy

Timeline

• Start date: 2013-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2013-12-17
• Last updated: 2022-03-31

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study