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

Official Title

A Phase I and Enrichment Study of Low-dose Metronomic Topotecan and Pazopanib in Pediatric Patients With Recurrent or Refractory Solid Tumours Including CNS Tumours


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 a fixed dose of pazopanib. 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 including CNS tumours. Pharmacokinetic and pharmacodynamic studies will be conducted to further define the exposure to and activity of LDM topotecan in combination with pazopanib.

Trial Description

Primary Outcome Measures:

  • Maximum tolerated dose (MTD) of low dose metronomic (LDM)Topotecan
  • Recommended phase 2 dose (RP2D) of LDM Topotecan
Secondary Outcome Measures:
  • Anti-tumour activity of LDM Topotecan in combination with Pazopanib
  • Pharmacokinetics of LDM Topotecan and Pazopanib
  • Anti-angiogenic activity of LDM Topotecan and Pazopanib

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Canadian Cancer Society

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