drugset / Trial / NCT03139331
PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma
Phase 1
Completed
16 enrolled
University of California, San Francisco
Alex's Lemonade Stand Foundation · collabDana-Farber Cancer Institute · collabUCSF Benioff Children's Hospital Oakland · collab
NaSingle-groupOpen-labelTreatment
Summary
This is the first study to evaluate the safety and clinical activity of the combination of oral pazopanib, intravenous or oral irinotecan, and oral temozolomide in pediatric and young adult patients with relapsed or refractory sarcomas. This study will use a 3 + 3 design for dose escalation (Part 1), followed by an expansion cohort (Part 2) at the recommended phase 2 dose level.
Timeline
- Start
- 2017-06-06
- Primary completion
- 2019-10-15
- Completion
- 2020-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 37.5 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 45 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 67.5 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Pazopanib | Small molecule | — | Oral |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |