SU5416 in Treating Patients With Metastatic Kidney Cancer That Has N...
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`https://clinicaltrials.gov/ct2/show/NCT00009919?term=NCT00009919&...
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`Trial record 1 of 1 for: NCT00009919
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`SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous
`Treatment
`
`This study has been terminated.
`(Administratively complete.)
`
`Sponsor:
`National Cancer Institute (NCI)
`
`Information provided by (Responsible Party):
`National Cancer Institute (NCI)
`
`ClinicalTrials.gov Identifier:
`NCT00009919
`
`First received: February 2, 2001
`Last updated: January 22, 2013
`Last verified: January 2013
`History of Changes
`
`Full Text View
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`Tabular View
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`No Study Results Posted
`
`Disclaimer
`
`D
`How to Read a Study Record
`
`(cid:141)
`
`Purpose
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`Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous
`therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor
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`Condition
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`Recurrent Renal Cell Cancer
`Stage IV Renal Cell Cancer
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`Intervention
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`Drug: semaxanib
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`Phase
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`Phase 2
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`Interventional
`Study Type:
`Study Design: Endpoint Classification: Efficacy Study
`Intervention Model: Single Group Assignment
`Masking: Open Label
`Primary Purpose: Treatment
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`Official Title:
`
`Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or
`5-Fluorouracil Containing Regimens
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`Resource links provided by NLM:
`
`MedlinePlus related topics: Cancer Kidney Cancer
`
`Genetic and Rare Diseases Information 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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`Primary Outcome Measures:
`•
`Rate of progression-free events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
`Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
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`Objective response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
`Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
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`1 of 4
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`12/5/2016 4:21 PM
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`NOVARTIS EXHIBIT 2067
`Breckenridge v. Novartis, IPR 2017-01592
`Page 1 of 4
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`SU5416 in Treating Patients With Metastatic Kidney Cancer That Has N...
`
`https://clinicaltrials.gov/ct2/show/NCT00009919?term=NCT00009919&...
`
`Secondary Outcome Measures:
`Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
`Analyzed using Kaplan Meier curves and Cox proportional hazards models.
`
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`Time to disease progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
`Analyzed using Kaplan Meier curves and Cox proportional hazards.
`
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`Time to treatment failure [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
`Analyzed using Kaplan Meier curves and Cox proportional hazards.
`
`
`Duration of response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
`Analyzed using Kaplan Meier curves and Cox proportional hazards.
`
`50
`Enrollment:
`December 2000
`Study Start Date:
`Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
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`Arms
`
`Experimental: Treatment (semaxanib)
`Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the
`absence of disease progression or unacceptable toxicity. Patients with CR receive an additional 6 months of therapy after
`achieving CR.
`
`Assigned
`Interventions
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`Drug: semaxanib
`Given IV
`Other Names:
`
`semoxind
`
`SU5416
`
`Sugen 5416
`
`Detailed Description:
`OBJECTIVES:
`I. Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing
`regimens.
`II. Determine the changes in tumor perfusion in patients treated with this regimen.
`III. Determine the time to progression and survival in patients treated with this regimen.
`OUTLINE:
`Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease
`progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR.
`Patients are followed every 3 months.
`
`
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`Eligibility
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`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`
`16 Years and older
`Bo h
`No
`
`(Child, Adult, Senior)
`
`Criteria
`Inclusion Criteria:
`
`Histologically confirmed metastatic renal cell carcinoma
`Prior removal of primary tumors
`Bidimensionally measurable disease
`Bone-only disease is not considered measurable
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`Progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy)
`orfluorouracil-containing (single-agent or in combination therapy) regimens
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`No known history of CNS metastasis unless all of the following are true:
`Previously treated
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`NOVARTIS EXHIBIT 2067
`Breckenridge v. Novartis, IPR 2017-01592
`Page 2 of 4
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`SU5416 in Treating Patients With Metastatic Kidney Cancer That Has N...
`
`https://clinicaltrials.gov/ct2/show/NCT00009919?term=NCT00009919&...
`
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`Neurologically stable
`No requirement for IV steroids or anticonvulsants
`No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI
`Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present
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`Performance status - Zubrod 0-2
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`At least 12 weeks
`
`Absolute neutrophil count at least 1,500/mm^3
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`Platelet count greater than 100,000/mm^3
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`Bilirubin no greater than 1.5 mg/dL
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`SGPT no greater than 2.5 times upper limit of normal
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`PT and PTT normal
`Fibrinogen normal
`D-Dimer assay normal
`Creatinine no greater than 1.5 mg/dL
`Creatinine clearance at least 60 mL/min
`
`See Surgery
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`No active congestive heart failure
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`No uncontrolled angina
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`No myocardial infarction or severe/unstable angina within the past 6 months
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`No uncontrolled hypertension
`No uncompensated coronary artery disease on electrocardiogram or physical examination
`No severe peripheral vascular disease
`No deep vein or arterial thrombosis within the past 3 months
`No pulmonary embolism wi hin the past 3 months
`
`Not pregnant or nursing
`
`Negative pregnancy test
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`Fertile patients must use effective contraception
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`No concurrent serious infection
`
`No overt psychosis, mental disability, or incompetence
`No diabetes mellitus
`No other prior malignancy within he past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
`No hypersensitivity or allergic reaction to paclitaxel
`See Disease Characteristics
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`No other concurrent anti-cancer biologic therapy
`
`See Disease Characteristics
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`No concurrent anti-cancer chemotherapy
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`See Disease Characteristics
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`At least 4 weeks since prior radiotherapy and recovered
`No sole indicator lesion within the previously irradiated port
`No concurrent anti-cancer radiotherapy
`See Disease Characteristics
`At least 4 weeks since prior major surgery and recovered
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`At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease
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`No concurrent surgery for cancer
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`No other inves igational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study
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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 his study by its ClinicalTrials.gov iden ifier: NCT00009919
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`NOVARTIS EXHIBIT 2067
`Breckenridge v. Novartis, IPR 2017-01592
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`SU5416 in Treating Patients With Metastatic Kidney Cancer That Has N...
`
`https://clinicaltrials.gov/ct2/show/NCT00009919?term=NCT00009919&...
`
`Locations
`
`United States, Texas
`M D Anderson Cancer Center
`Houston, Texas, United States, 77030
`
`Sponsors and Collaborators
`National Cancer Ins itute (NCI)
`
`Investigators
`Principal Investigator: Arlene Siefker-Radtke M.D. Anderson Cancer Center
`
`
`
`More Information
`
`National Cancer Institute (NCI)
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT00009919 History of Changes
`Other Study ID Numbers:
`NCI-2012-02373 ID99-291 N01CM17003 CDR0000068424
`Study First Received:
`February 2, 2001
`Last Updated:
`January 22, 2013
`Health Authority:
`United States: Food and Drug Administration
`
`Additional relevant MeSH terms:
`Carcinoma, Renal Cell
`Adenocarcinoma
`Carcinoma
`Neoplasms, Glandular and Epithelial
`Neoplasms by Histologic Type
`Neoplasms
`Kidney Neoplasms
`Urologic Neoplasms
`Urogenital Neoplasms
`Neoplasms by Site
`Kidney Diseases
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`Urologic Diseases
`Semaxinib
`Angiogenesis Inhibitors
`Angiogenesis Modulating Agents
`Growth Substances
`Physiological Effects of Drugs
`Growth Inhibitors
`Antineoplastic Agents
`Protein Kinase Inhibitors
`Enzyme Inhibitors
`Molecular Mechanisms of Pharmacological Action
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`ClinicalTrials.gov processed this record on December 05, 2016
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`4 of 4
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`12/5/2016 4:21 PM
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`NOVARTIS EXHIBIT 2067
`Breckenridge v. Novartis, IPR 2017-01592
`Page 4 of 4
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