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Vascular Endothelial Growth Factor Receptor and Platelet-Derived Growth Factor Receptor inhibitor

Phase 2

Kidney Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jun 26, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Vascular Endothelial Growth Factor Receptor and Platelet-Derived Growth Factor Receptor inhibitor · 1 trial · 1 indication

Phase 2 1
NCT00076011Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell CarcinomaKidney Neoplasms
COMPLETED52 Analytics
PHASE2COMPLETED
Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
Kidney Neoplasms
NCT0007601152
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Study Endpoints

Primary Endpoints

Percentage of Participants With Objective Response (OR)
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Secondary Endpoints

Time to Disease Progression (TTP)
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Duration of Response (DR)
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Overall Survival (OS)
Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitorDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Histologically documented RCC with metastases. * Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity Exclusion Criteria: * Any prior systemic treatment for Renal Cell Carcinoma \[RC...

Countries:United StatesFranceGermany
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