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Pazopanib 2 week

Phase 1

Carcinoma, Renal Cell | Small molecule | Oncology |GSK plc|Last Updated: Nov 13, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00992121An Open-Label Pharmacodynamic Study of Bevacivumab and Pazopanib in Renal Cell CarcinomaPHASE1 COMPLETED 11Nov 18, 2009Nov 1, 2013Nov 13, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Tumour size, as measured by the sum of the longest diameters of all target lesions on CT
6 weeks
Secondary Endpoints
Plasma levels of pharmacodynamic markers of study drug effect
6 weeks Part I; 15 weeks Part II; 6 weeks during maintenance therapy
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Part I and 2 week dosing Part IIOTHERPart I - bevacizumab 3 infusions at 2 week intervals Part II - pazopanib dosing 2 weeks in 3-week cycles
Part I and 3 week dosing Part IIOTHERPart I - bevacizumab 3 infusions at 2 week interval, Part II - pazopanib dosing 3 weeks in 3-week cycles
Interventions
NameTypeDescription
BevacizumabDRUGBevacizumab - 3 infusions of 10mg/kg administered at 2 week intervals - Part I
Pazopanib 2 weekDRUGPazopanib for first 2 weeks of each 3-week cycles as follows: 1) 200 mg twice weekly, 2) 200 mg every other day, 3) 200 mg qd, 4) 400 mg qd, 5) 800 mg qd, and 6) 1200 mg qd (Group 1). Maintenance pazopanib 800 mg qd for all 3 weeks throughout repeating 3-week cycles. Number of cycles: until death, loss of clinical benefit, unacceptable toxicity, or withdrawal from the study for other reasons.
Pazopanib 3 weekDRUGPazopanib throughout each 3-week cycle as follows: 1) 200 mg twice weekly, 2) 200 mg every other day, 3) 200 mg qd, 4) 400 mg qd, 5) 800 mg qd, and 6) 1200 mg qd (Group 1). Maintenance pazopanib 800 mg qd for all 3 weeks throughout repeating 3-week cycles. Number of cycles: until death, loss of clinical benefit, unacceptable toxicity, or withdrawal from the study for other reasons.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically (any histological subtype) or cytologically confirmed unresectable RCC with a clear cell component. * Experienced documented evidence of radiological progression based on Response Evaluation Criteria in Solid Tumors \[RECIST\] while on first line (or greater) RC...

Countries:United Kingdom
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