CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Bevacizumab +3 morebiological
Likely dose
Sorafenib tosylate (oral) and bevacizumab (IV); specific dose not stated in trial recordAI-extracted
Key inclusion· 7
  • Histologically or cytologically confirmed renal cell carcinoma (clear cell, papillary, chromophobe, or sarcomatoid) not curable by standard approaches
  • Measurable disease by RECIST criteria
  • ECOG performance status 0 or 1
  • Life expectancy >3 months
Key exclusion· 14
  • Prior therapy with MAPK pathway or VEGFR inhibitors (including sunitinib, VEGF Trap, sorafenib, bevacizumab, temsirolimus, everolimus)
  • Prior anti-angiogenic therapy (sunitinib, VEGF Trap); sorafenib, bevacizumab, temsirolimus, everolimus not allowed as prior therapy
  • CNS metastases, except resected/radiosurgery with >6 months no progression if PI approves; prior meningioma allowed; controlled seizures allowed
  • Chemotherapy/immunotherapy within 4 weeks; monoclonal antibody within 8 weeks of treatment start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00126503
NCT00126503Phase 2Completed

A Phase I/II Trial of BAY 43-9006 in Combination With Bevacizumab in Patients With Advanced Renal Cancer

National Cancer Institute (NCI)·interventional·Posted Aug 4, 2005·Updated Jan 15, 2015

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Sorafenib Tosylate, and 2 other interventions for Chromophobe Renal Cell Carcinoma and 5 related conditions. Completed, enrolled 73 participants across 5 sites.

Detailed Summary

This phase I/II trial studies the side effects and best dose of sorafenib tosylate and bevacizumab and to see how well they work in treating patients with advanced kidney cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth by targeting certain cells. Bevacizumab and sorafenib tosylate may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib tosylate together with bevacizumab may kill more tumor cells.

Study Details

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 4, 2005
Enrollment StartMay 1, 2005
Primary CompletionOct 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.9 years ago

Interventions

Bevacizumabbiological

Given IV

Sorafenib Tosylatedrug

Given PO

Pharmacological Studyother

Correlative studies

Laboratory Biomarker Analysisother

Correlative studies