Status:
COMPLETED
AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib
Lead Sponsor:
Amgen
Conditions:
Advanced Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcin...
Eligibility Criteria
Inclusion
- Subjects must have a histologically confirmed metastatic renal cell cancer (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 Response Evaluation Criteria in Solid Tumor (RECIST) guidelines with modifications
- Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Exclusion
- Disease related
- Known history of central nervous system metastases.
- Previous treatment (excluding surgery, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
- Focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment.
- Medications
- Currently or previously treated with sunitinib or other small molecule inhibitors of vascular endothelial growth factor (VEGF)
- Currently or previously treated with agents that neutralizing VEGF
- Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
- Currently or previously treated with agents inhibiting the mammalian target of rapamycin (mTOR)
- Current or within 30 days prior to enrollment treatment with immune modulators
- Concomitant or previous use within 30 days prior to enrollment of any strong inducer of CYP3A4
- Concomitant or previous use of amiodarone within 6 months prior to enrollment
- General medical
- Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
- Major surgery within 28 days prior to enrollment or still recovering from prior surgery
- Uncontrolled hypertension as defined as diastolic \> 90 mmHg OR systolic \>150 mmHg. The use of anti-hypertensive medications to control hypertension is 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)
- Other inclusion/exclusion criteria may apply, per protocol.
Key Trial Info
Start Date :
May 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2019
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00853372
Start Date
May 28 2009
End Date
June 25 2019
Last Update
July 1 2020
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