drugset / Trial / NCT04337177
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma
Timeline
- Start
- 2021-10-25
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VAL-413 | Unknown | 75 mg/m2 | Oral |
| Subject | VAL-413 | Unknown | 90 mg/m2 | Oral |
| Subject | VAL-413 | Unknown | 110 mg/m2 | Oral |
| Background | Temozolomide | Small molecule | 100 mg/m2 | Oral |