AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
NCT ID: NCT00467025
Last Updated: 2016-03-23
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
PHASE2
152 participants
INTERVENTIONAL
2007-05-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Arm A
AMG 386
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
Sorafenib
400 mg PO BID
AMG 386 placebo IV
AMG 386 placebo IV
Arm B
AMG 386
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
Sorafenib
400 mg PO BID
Arm C
Sorafenib
400 mg PO BID
AMG 386 placebo IV
AMG 386 placebo IV
Interventions
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AMG 386
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
Sorafenib
400 mg PO BID
AMG 386 placebo IV
AMG 386 placebo IV
Eligibility Criteria
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Inclusion Criteria
* Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification.
* Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications
* Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening.
* ECOG of 0 or 1
Exclusion Criteria
* Known history of central nervous system metastases.
* Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
* Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization.
Medications
* Currently or previously treated with inhibitors of VEGF.
* Currently or previously treated with inhibitors of angiopoietin or Tie2.
* Currently or previously treated with bevacizumab.
General Medical
* Diagnosis of acute pancreatitis.
* Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization
* Major surgery within 30 days before randomization or still recovering from prior surgery
* Uncontrolled hypertension as defined as diastolic \> 90 mmHg OR systolic \>150 mmHg. Anti-hypertensive medications are permitted.
Other
* Other investigational procedures are excluded
* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Rini B, Szczylik C, Tannir NM, Koralewski P, Tomczak P, Deptala A, Dirix LY, Fishman M, Ramlau R, Ravaud A, Rogowski W, Kracht K, Sun YN, Bass MB, Puhlmann M, Escudier B. AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. Cancer. 2012 Dec 15;118(24):6152-61. doi: 10.1002/cncr.27632. Epub 2012 Jun 12.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20060159
Identifier Type: -
Identifier Source: org_study_id
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