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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00397787
Other study ID # NCI-2012-02823
Secondary ID CALGB-80603U10CA
Status Completed
Phase Phase 2
First received November 9, 2006
Last updated June 3, 2013
Start date November 2006

Study information

Verified date June 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.


Description:

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Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
sunitinib malate
Given PO

Locations

Country Name City State
United States Cancer and Leukemia Group B Chicago Illinois
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response (CR/PR/stable disease) as measured by RECIST criteria At 6 weeks post-initiation of protocol treatment No
Secondary Response duration Duration of response will be determined for the subset of patients who achieve a confirmed response of CR or PR. Duration of objective response will be defined as the time from the first tumor assessment indicating response (later confirmed) to the time of disease progression or death from any cause. Up to 2 years No
Secondary Progression-free survival (PFS) Median and 1-year survival will be assessed using Kaplan-Meier methods. Up to 2 years No
Secondary Number and percentage of patients reporting common and serious adverse events (AEs), the AEs related to sunitinib, reason for study discontinuation, clinically significant laboratory abnormalities, and AEs with worst NCI CTCAE grade Summarized descriptively for all patients receiving at least one dose of sunitinib. Up to 2 years Yes
Secondary Overall survival (OS) Median and 1-year survival will be assessed using Kaplan-Meier methods. Up to 2 years No
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