drugset / Trial / NCT02303028

Phase I Dose Escalation Study of Topotecan and Pazopanib in Children With Recurrent/Refractory Solid Tumours

NCT02303028

Phase 1/2 Completed 30 enrolled The Hospital for Sick Children C17 Council · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I, dose escalation study where topotecan will be administered at lower doses given more frequently on a prolonged schedule (low dose metronomic; LDM), in combination with pazopanib administered in a specific dose range. The maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) will be evaluated for LDM topotecan in combination with pazopanib in children with recurrent or refractory solid tumours. Pharmacokinetic and pharmacodynamic studies will be conducted to further define the exposure to and activity of LDM topotecan in combination with pazopanib.

Timeline

Start
2015-03
Primary completion
2022-06-17
Completion
2022-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Pazopanib Small molecule
Subject Topotecan Small molecule

Indications