drugset / Trial / NCT05620862
Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors
Phase 1
Active not recruiting
68 enrolled
Sun Yat-sen University
CSPC Ouyi Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
Phase I dose escalation clinical trial: to explore the dose limiting toxicity (DLT) of mitoxantrone hydrochloride liposome injection in the treatment of children with relapsed and refractory lymphoma and solid tumors. Pharmacokinetics clinical trial: to observe the pharmacokinetics of mitoxantrone hydrochloride liposomes in children with relapsed and refractory lymphoma and solid tumors. To evaluate the safety and efficacy of mitoxantrone hydrochloride liposomes in children with lymphoma and solid tumors.
Timeline
- Start
- 2022-10-25
- Primary completion
- 2024-09-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 50 mg/m2 | — |
| Subject | Mitoxantrone | Small molecule | 16 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 24 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | — |