Status:
COMPLETED
AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
Lead Sponsor:
Amgen
Conditions:
Advanced Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 i...
Eligibility Criteria
Inclusion
- Subjects must have a histologically confirmed metastatic RCC with a clear cell component
- 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
- Disease Related
- 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)
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00467025
Start Date
May 1 2007
End Date
June 1 2014
Last Update
March 23 2016
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