At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 42 enrolled
Drug / intervention
Gefitinib + Sunitinibdrug
Likely dose
Sunitinib and gefitinib (specific doses not stated in arms/interventions)AI-extracted
Key inclusion· 3
- ✓Histologically confirmed renal cell carcinoma with metastases
- ✓Measurable disease by imaging
- ✓No prior systemic therapy for metastatic RCC or failure of 1 prior immunotherapy
Key exclusion· 4
- ✕RCC without clear cell component (e.g., pure papillary, chromophobe)
- ✕History of or known brain metastases
- ✕Uncontrolled hypertension
- ✕Significant cardiac events within 12 months prior to study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Gefitinib + Sunitinib for Carcinoma, Renal Cell. Completed, enrolled 42 participants across 3 sites.
Detailed Summary
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
First PostedJun 2005
Primary CompletionSep 2007
Study CompletionOct 2008
TodayJul 2026
First PostedJun 9, 2005
Enrollment StartOct 1, 2004
Primary CompletionSep 1, 2007
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 21.1 years ago
Interventions
Gefitinib + Sunitinibdrug
Until disease progression or unacceptable toxicity.