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

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Ewing Sarcoma
Liver/ Hepatoblastoma
Neuroblastoma
Rhabdomyosarcoma
Trial Phase
Phase II
Eligibility
1 to 18, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01956669
Protocol IDs
116731 (primary)
NCI-2015-00058
Study Sponsor
GlaxoSmithKline

Summary

The purpose of this study is to find out what effects, good or bad, pazopanib (GW786034),

National Service Center (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 tumors. 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.

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