At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Everolimus 2.5 mg orally daily in combination with imatinib mesylate 600 mg orally dailyAI-extracted
Key inclusion· 3
- ✓Histologically confirmed clear cell renal carcinoma with measurable metastatic disease or locally unresectable disease
- ✓Must have received ≥1 prior systemic therapy for metastatic or unresectable renal cell carcinoma
- ✓ECOG performance status 0-2
Key exclusion· 9
- ✕Known brain metastases that have not been adequately treated with radiotherapy and/or surgery
- ✕Prior treatment with an mTOR inhibitor
- ✕Other malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or insignificant/inactive disease
- ✕Chronic liver disease (chronic active hepatitis or cirrhosis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
In Brief
A Phase 2 clinical trial evaluating Everolimus and imatinib mesylate for Kidney Cancer. Completed, enrolled 23 participants across 1 site.
Detailed Summary
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedMay 2006
Primary CompletionJan 2010
TodayJul 2026
First PostedMay 31, 2006
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.1 years ago
Interventions
Everolimusdrug
2.5 mg by mouth daily
imatinib mesylatedrug
600 mg by mouth daily