Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
NCT ID: NCT00267748
Last Updated: 2011-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
317 participants
INTERVENTIONAL
2005-12-31
2010-06-30
Brief Summary
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The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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C
Sunitinib Malate Continuous Daily Dosing
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
A
Sunitinib Malate Schedule 4/2
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
Interventions
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Sunitinib Malate Continuous Daily Dosing
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
Sunitinib Malate Schedule 4/2
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
Eligibility Criteria
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Inclusion Criteria
* Measurable disease
Exclusion Criteria
* History of brain metastases
* Uncontrolled hypertension
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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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Baldwin Park, California, United States
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Bellflower, California, United States
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Duarte, California, United States
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Fontana, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Panorama City, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Woodland Hills, California, United States
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Lone Tree, Colorado, United States
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Longmont, Colorado, United States
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Parker, Colorado, United States
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Pueblo, Colorado, United States
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Thorton, Colorado, United States
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Norwich, Connecticut, United States
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Newark, Delaware, United States
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Newark, Delaware, United States
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Wilmington, Delaware, United States
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Boca Raton, Florida, United States
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Delray Beach, Florida, United States
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Lakeland, Florida, United States
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Orlando, Florida, United States
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Columbus, Georgia, United States
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Columbus, Georgia, United States
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Boise, Idaho, United States
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Elkhart, Indiana, United States
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Jefferson, Indiana, United States
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Kokomo, Indiana, United States
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La Porte, Indiana, United States
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La Porte, Indiana, United States
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Michigan City, Indiana, United States
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Plymouth, Indiana, United States
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South Bend, Indiana, United States
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South Bend, Indiana, United States
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Cedar Rapids, Iowa, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Shelbyville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Covington, Louisiana, United States
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Gretna, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Grand Rapids, Michigan, United States
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Holland, Michigan, United States
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Niles, Michigan, United States
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Saint Joseph, Michigan, United States
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Saint Joseph, Michigan, United States
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Saint Joseph, Michigan, United States
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St Louis, Missouri, United States
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Washington, Missouri, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Hackensack, New Jersey, United States
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Albuquerque, New Mexico, United States
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Farmington, New Mexico, United States
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Albany, New York, United States
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Albany, New York, United States
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Amsterdam, New York, United States
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Brockport, New York, United States
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Canadaigua, New York, United States
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Geneva, New York, United States
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Hudson, New York, United States
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Latham, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rexford, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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Troy, New York, United States
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Cary, North Carolina, United States
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Clinton, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Goldsboro, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilson, North Carolina, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Springfield, Oregon, United States
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Dunmore, Pennsylvania, United States
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Lemoyne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Easley, South Carolina, United States
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Greenville, South Carolina, United States
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Greenville, South Carolina, United States
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Seneca, South Carolina, United States
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Spartanburg, South Carolina, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Webster, Texas, United States
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Salt Lake City, Utah, United States
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Chesapeake, Virginia, United States
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Hampton, Virginia, United States
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Newport News, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Williamsburg, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
Countries
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References
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de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
Motzer RJ, Hutson TE, Hudes GR, Figlin RA, Martini JF, English PA, Huang X, Valota O, Williams JA. Investigation of novel circulating proteins, germ line single-nucleotide polymorphisms, and molecular tumor markers as potential efficacy biomarkers of first-line sunitinib therapy for advanced renal cell carcinoma. Cancer Chemother Pharmacol. 2014 Oct;74(4):739-50. doi: 10.1007/s00280-014-2539-0. Epub 2014 Aug 7.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181065
Identifier Type: -
Identifier Source: org_study_id
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