A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors
NCT ID: NCT00615446
Last Updated: 2010-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2005-03-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
SU011248; Gemcitabine
Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity
Interventions
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SU011248; Gemcitabine
Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has good performance status (ECOG 0 or 1)
Exclusion Criteria
* Hypertension that cannot be controlled by medications
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Countries
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References
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Michaelson MD, Zhu AX, Ryan DP, McDermott DF, Shapiro GI, Tye L, Chen I, Stephenson P, Patyna S, Ruiz-Garcia A, Schwarzberg AB. Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dose-finding study. Br J Cancer. 2013 Apr 16;108(7):1393-401. doi: 10.1038/bjc.2013.96. Epub 2013 Mar 19.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181041
Identifier Type: -
Identifier Source: org_study_id