Conditions: Carcinoma, Renal Cell
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib

Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib

Interventions: intervention 1: Gefitinib + Sunitinib
Intervention descriptions: intervention 1: Until disease progression or unacceptable toxicity.

Protocol document: