AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib
Condition: Advanced Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sunitinib; Trebananib
Intervention description: Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants.; Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.
Intervention MeSH terms: Sunitinib; Trebananib; Angiogenesis Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

        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.