Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumours

Official Title

A Phase II Study of Pazopanib GW786034, NSC# 737754 in Children, Adolescents and Young Adults With Refractory Solid Tumours


The purpose of this study is to find out what effects, good or bad, pazopanib (GW786034), National Service Centre (NSC) # 737754, has on children, adolescents and young adults between 12 months and less than or equal to 18 years of age with relapsed or refractory rhabdomyosarcoma, non rhabdomyosarcomatous soft tissue sarcoma, Ewing sarcoma, relapsed or refractory osteosarcoma, neuroblastoma (measurable and/or evaluable), or hepatoblastoma. This is a two-stage open label phase II trial of pazopanib in children, adolescents and young adults with recurrent or refractory solid tumours. Eligible subjects will receive pazopanib daily as an oral tablet (450 mg/m^2/dose) or as a powder for suspension (225 mg/m^2/dose) in 28 day cycles. The maximum dose to be administered daily for tablets is 800 mg and for suspension 400 mg. Subjects will be closely monitored with clinical and laboratory observations for side effects. Response to treatment will be evaluated using appropriate imaging studies. In the absence of severe toxicity or progressive disease, subjects may continue receiving pazopanib.

Trial Description

Primary Outcome:

  • The investigator assessed objective response rate (ORR) in subjects' with tumours of primary interest
Secondary Outcome:
  • The investigator assessed ORR for the tumour types of secondary interest.
  • Incidence of toxicities of oral pazopanib
  • Progression free survival (PFS) as assessed by the Investigator in subjects with relapsed or refractory solid tumours
  • The time to progression (TTP) in subjects with relapsed or refractory solid tumours
  • To determine the therapeutic activity (a confirmed complete or partial response or stable disease for at least 4 cycles) per cohort
  • The relationship between tumour response and angiogenic cytokines.
  • genotype/phenotype of VEGF or other members of the VEGF signaling pathway
  • Pazopanib pharmacokinetic/pharmacodynamic relationships with biomarkers and clinical outcomes
  • Composite of pharmacokinetic (PK) parameters of pazopanib after administration of the oral suspension
  • Overall Survival (OS)
  • Duration of response

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