Spots Global Cancer Trial Database for Phase I Dose Escalation Study of Topotecan and Pazopanib in Children With Recurrent/Refractory Solid Tumours
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Trial Identification
Brief Title: Phase I Dose Escalation Study of Topotecan and Pazopanib in Children With Recurrent/Refractory Solid Tumours
Official Title: A Phase I and Enrichment Study of Low-dose Metronomic Topotecan and Pazopanib in Pediatric Patients With Recurrent or Refractory Solid Tumours
Study ID: NCT02303028
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alberta Children's Hospital, Calgary, Alberta, Canada
BC Children's Hospital, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital, Hamilton, Ontario, Canada
Children's Hospital, London Health Sciences Centre, London, Ontario, Canada
Children's Hospital of Eastern Ontario (CHEO), Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
CHU St. Justine Hopital, Montreal, Quebec, Canada
Contact Details
Name: Jim Whitlock
Affiliation: The Hospital for Sick Children
Role: STUDY_CHAIR
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