CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 903 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +1 moredrug
Likely dose
Sorafenib 400 mg orally twice dailyAI-extracted
Key inclusion· 5
  • ✓Unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
  • ✓One prior systemic therapy for advanced disease, completed 30 days to 8 months prior to randomization
  • ✓At least one uni-dimensional measurable lesion by CT or MRI per RECIST
  • ✓ECOG performance status 0 or 1
Key exclusion· 10
  • ✕Rare RCC subtypes (pure papillary, predominantly sarcomatoid, Bellini, medullary, chromophobe oncocytic)
  • ✕Prior raf-kinase inhibitors, MEK inhibitors, or farnesyl transferase inhibitors
  • ✕Prior bevacizumab or other VEGF/VEGF receptor-targeting drugs
  • ✕History of metastatic brain or meningeal tumors

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

Search/NCT00073307
NCT00073307Phase 3Completed
CompareCT.gov

A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

Bayer·interventional·Posted Nov 21, 2003·Updated Feb 6, 2014

In Brief

A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Placebo for Carcinoma, Renal Cell. Completed, enrolled 903 participants across 121 sites in 19 countries.

Detailed Summary

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, South Africa, Spain, Ukraine, United Kingdom, United States
CollaboratorsAmgen

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 21, 2003
Enrollment StartNov 1, 2003
Primary CompletionSep 1, 2006
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.6 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006)drug

Multi Kinase Inhibitor

Placebodrug

Placebo