Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
NCT ID: NCT00137423
Last Updated: 2009-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2005-05-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SU011248 (sunitinib)
Single-arm study
SU011248 (sunitinib)
37.5 mg/day, oral, continuous daily dosing
Interventions
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SU011248 (sunitinib)
37.5 mg/day, oral, continuous daily dosing
Eligibility Criteria
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Inclusion Criteria
* Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
* Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated with IFN-á alone must have received IFN-á for at least 4 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1.
* Adequate organ function
Exclusion Criteria
* Previous treatment on a SU011248 (sunitinib) clinical trial.
* Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
* Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
* Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval \>450 msec for males or \>470 msec for females.
* Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy).
* Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
* Known human immunodeficiency virus (HIV) infection.
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
Stanford, California, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Villejuif, , France
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Thessaloniki, , Greece
Pfizer Investigational Site
Nijmegen, Gelderland, Netherlands
Pfizer Investigational Site
Lund, , Sweden
Pfizer Investigational Site
Stockholm, , Sweden
Pfizer Investigational Site
Sankt Gallen, , Switzerland
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.
Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, Fountzilas G, Peschel C, Flodgren P, Maneval EC, Chen I, Vogelzang NJ. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009 Sep 1;27(25):4068-75. doi: 10.1200/JCO.2008.20.5476. Epub 2009 Aug 3.
Related Links
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Other Identifiers
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A6181061
Identifier Type: -
Identifier Source: org_study_id