At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic renal cell carcinoma with clear cell component
- ✓Low or intermediate risk disease by MSKCC prognostic classification
- ✓At least one measurable lesion per RECIST criteria
- ✓ECOG performance status 0 or 1
- ✕Known CNS metastases
- ✕Prior treatment for advanced/metastatic RCC (except surgery, cytokine-based immunotherapy, or palliative radiotherapy)
- ✕Prior VEGF small molecule inhibitors (including sunitinib)
- ✕Prior VEGF-neutralizing agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Sunitinib Malate in Combination With AMG 386 as First Line or Second Line Therapy for Subjects With Metastatic Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Sunitinib and Trebananib for Advanced Renal Cell Carcinoma. Completed, enrolled 85 participants.
Detailed 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.
Study Details
Timeline
Interventions
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.