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Sunitinib Continuous Daily Dosing

Phase 2

Carcinoma, Renal Cell | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 5, 2011

Target and mechanism

ModalitySmall molecule

Also known as Sunitinib Malate Continuous Daily Dosing

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment317

FDA Designations

No designations recorded

Clinical trial landscape

Sunitinib Continuous Daily Dosing · 1 trial · 1 indication

Phase 2 1
NCT00267748Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)Carcinoma, Renal Cell
COMPLETED317 Analytics
PHASE2COMPLETED
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
Carcinoma, Renal Cell
NCT00267748317
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Study Endpoints

Primary Endpoints

Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.

Secondary Endpoints

Percentage of Participants With Objective Response (OR)
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Duration of Response (DR)
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CEXPERIMENTAL -
AEXPERIMENTAL -

Interventions

NameTypeDescription
Sunitinib Malate Continuous Daily DosingDRUGSunitinib malate starting dose 37.5 mg daily continuous daily regimen.
Sunitinib Malate Schedule 4/2DRUGSunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites156

Inclusion Criteria: * Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology. * Measurable disease Exclusion Criteria: * Prior systemic therapy of any kind for advanced renal cell cancer * History of brain metastases * Uncontrolled hypertension

Countries:United States
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