Monoclonal Antibody Therapy in Treating Patients With Advanced Kidn...
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`https://clinicaltrials.gov/ct2/show/NCT00019539?term=NCT00019539&...
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`Trial record 1 of 1 for: NCT00019539
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`Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
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`This study has been completed.
`
`Sponsor:
`National Cancer Institute (NCI)
`
`Information provided by:
`National Cancer Institute (NCI)
`
`ClinicalTrials.gov Identifier:
`NCT00019539
`
`First received: January 9, 2009
`Last updated: June 19, 2013
`Last verified: October 2004
`History of Changes
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`No Study Results Posted
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`Purpose
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`RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to hem.
`PURPOSE: Randomized phase II trial to determine the effec iveness of monoclonal antibody therapy in treating patients who have advanced kidney
`cancer that cannot be surgically removed.
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`Condition
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`Stage IV Renal Cell Cancer
`Recurrent Renal Cell Cancer
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`Intervention
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`Drug: bevacizumab
`Drug: thalidomide
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`Phase
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`Phase 2
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`Interventional
`Study Type:
`Study Design: Primary Purpose: Treatment
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`Official Title:
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`Phase II Randomized Study of Monoclonal Antibody VEGF in Patients With Unresectable Advanced Renal Cell Cancer
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`Resource links provided by NLM:
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`MedlinePlus related topics: Cancer
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`Genetic and Rare Diseases Informa ion Center resources: Kidney Cancer Renal Cancer
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`U.S. FDA Resources
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`Further study details as provided by National Cancer Institute (NCI):
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`November 1998
`Study Start Date:
`Study Completion Date: November 2004
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`Detailed Description:
`OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression, angiogenesis, and overall survival in pa ients with
`unresectable advanced renal cell cancer.
`II. Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this
`regimen.
`III. Evaluate the toxicity of this regimen in these patients.
`PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by prior interleukin-2 therapy (yes vs no).
`Patients are randomized to receive either placebo or one of two doses of monoclonal antibody VEGF. Following an initial loading dose, patients
`receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression. Patients who are given
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`12/5/2016 4:21 PM
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`NOVARTIS EXHIBIT 2066
`Breckenridge v. Novartis, IPR 2017-01592
`Page 1 of 3
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`Monoclonal Antibody Therapy in Treating Patients With Advanced Kidn...
`
`https://clinicaltrials.gov/ct2/show/NCT00019539?term=NCT00019539&...
`
`placebo and experience disease progression are offered monoclonal antibody VEGF and thalidomide if there are no contraindications.
`PROJECTED ACCRUAL:
`A total of 150 patients will be accrued for this study over 2 years.
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`(cid:141)
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`Eligibility
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`Ages Eligible for Study:
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`18 Years and older
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`(Adult, Senior)
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`Criteria
`PROTOCOL ENTRY CRITERIA:
`--Disease Characteristics-- Histologically proven unresectable advanced renal cell cancer Measurable disease Must have received or not be a
`suitable candidate for interleukin-2 therapy No papillary or collecting duct renal cell cancer No CNS metastases --Prior/Concurrent Therapy--
`Biologic therapy: See Disease Characteristics No prior thalidomide At least 4 weeks since other prior biologic therapy No other concurrent biologic
`therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior
`endocrine therapy No concurrent corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy
`Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6
`months Hematopoietic: WBC at least 1,000/mm3 Platelet count at least 75,000/mm3 No coagulation disorder, active bleeding, or wound healing
`problem Hepatic: Total bilirubin no greater than 2.0 mg/dL (for patients with Gilbert's disease, direct bilirubin less than 0.5 mg/dL) SGOT or SGPT
`no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No coronary artery disease Other: Not pregnant or
`nursing Negative pregnancy test Fertile patients must use effective contraception No clinically evident preexisting peripheral neuropathy
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`(cid:141)
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`Contacts and Locations
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
`study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
`information, see Learn About Clinical Studies.
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00019539
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`Locations
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`United States, Maryland
`Surgery Branch
`Bethesda, Maryland, United States, 20892
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`Sponsors and Collaborators
`National Cancer Institute (NCI)
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`Investigators
`Study Chair: James Chung-Yin Yang National Cancer Institute (NCI)
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`(cid:141)
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`More Information
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`ClinicalTrials.gov Identifier: NCT00019539 History of Changes
`Obsolete Identifiers:
`NCT00001707
`Other Study ID Numbers:
`CDR0000066669 NCI-98-C-0159 NCI-T98-0035
`Study First Received:
`January 9, 2009
`Last Updated:
`June 19, 2013
`Health Authority:
`United States: Federal Government
`
`Keywords provided by National Cancer Institute (NCI):
`adult solid tumor
`body system/site cancer
`cancer
`kidney tumor
`kidney/urinary cancer
`
`Additional relevant MeSH terms:
`Carcinoma, Renal Cell
`Adenocarcinoma
`Carcinoma
`Neoplasms, Glandular and Epithelial
`Neoplasms by Histologic Type
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`recurrent renal cell cancer
`renal cell cancer
`solid tumor
`stage IV renal cell cancer
`stage, renal cell cancer
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`Antibodies
`Antibodies, Monoclonal
`Angiogenesis Inhibitors
`Angiogenesis Modulating Agents
`Growth Substances
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`12/5/2016 4:21 PM
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`NOVARTIS EXHIBIT 2066
`Breckenridge v. Novartis, IPR 2017-01592
`Page 2 of 3
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`Monoclonal Antibody Therapy in Treating Patients With Advanced Kidn...
`
`https://clinicaltrials.gov/ct2/show/NCT00019539?term=NCT00019539&...
`
`Neoplasms
`Kidney Neoplasms
`Urologic Neoplasms
`Urogenital Neoplasms
`Neoplasms by Site
`Kidney Diseases
`Urologic Diseases
`Bevacizumab
`Thalidomide
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`ClinicalTrials.gov processed this record on December 05, 2016
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`Physiological Effects of Drugs
`Growth Inhibitors
`Antineoplastic Agents
`Immunologic Factors
`Immunosuppressive Agents
`Leprostatic Agents
`Anti-Bacterial Agents
`Anti-Infective Agents
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`3 of 3
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`12/5/2016 4:21 PM
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`NOVARTIS EXHIBIT 2066
`Breckenridge v. Novartis, IPR 2017-01592
`Page 3 of 3
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