At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 78 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
- ✓Metastatic or unresectable locally recurrent clear cell renal carcinoma, clinically documented
- ✓Prior nephrectomy, except if tumor <5 cm or extensive liver/bone metastasis present
- ✓Up to 1 prior treatment regimen with immunotherapy or chemotherapy allowed
- ✓ECOG performance status 0-1
Key exclusion· 8
- ✕Prior treatment with sorafenib or mTOR inhibitors
- ✕Acute myocardial infarction within the last 6 months
- ✕Active brain metastasis or meningeal metastases
- ✕Prior cancer treatment within the last 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Sorafenib and RAD001 for Kidney Cancer. Completed, enrolled 78 participants across 11 sites.
Detailed Summary
This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer. Participants will be asked to keep a pill diary.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesUnited States
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2006
Enrollment StartDec 2006
Primary CompletionOct 2013
TodayJul 2026
First PostedOct 26, 2006
Enrollment StartDec 1, 2006
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 19.7 years ago
Interventions
Sorafenibdrug
Sorafenib
RAD001drug
RAD001