A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors

Phase 1/2 Completed 13 enrolled Hutchmed

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory solid tumors or lymphoma. The study will be conducted in 2 parts.

Timeline

Start: 2021-11-30
Primary completion: 2023-04-25
Completion: 2023-04-25

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Surufatinib	Small molecule	—	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors

Summary

Timeline

Drugs

Indications