A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

July 8, 2008

Primary Completion Date

June 11, 2012

Study Completion Date

February 25, 2014

Conditions
Neoplasms, Breast
Interventions
DRUG

Doxorubicin

Arm D - doxorubicin given as a intravenous bolus injection on Day 1 or Day 3 depending on schedule selected from Arm A, B or C - starting dose 60 mg/m2 and increase to 75mg/m2

DRUG

Pazopanib (GW786034)

Arm A - daily administration of pazopanib on Days 1 through 21 starting at 200mg with a maximum dose of 800mg; Arm B daily administration of pazopanib on Days 1 through 8 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm C daily dose of pazopanib on Days 14 through 21 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm D once daily administration of pazopanib (according to schedule selected from Arm A, B, or C) starting at 400mg escalating to a maximum dose of 800mg

DRUG

Epirubicin

Arm A and Arm B - epirubicin given as a bolus intravenous injection on Day 3 starting dose 60mg/m2 increase to 90mg/m2 if tolerated; Arm C - epirubicin given as a bolus intravenous injection on Day 1 starting dose 60mg/m2 increase to 90mg/m2 if tolerated

Trial Locations (4)

1011

GSK Investigational Site, Lausanne

9007

GSK Investigational Site, Sankt Gallen

20133

GSK Investigational Site, Milan

Unknown

GSK Investigational Site, Bellinzona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00722293 - A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors | Biotech Hunter | Biotech Hunter