Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Gefitinib + Sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113529

A6181038

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed renal cell carcinoma with metastases
• Evidence of unidimensionally measurable disease
• Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC

Exclusion criteria

• RCC without any clear (conventional) cell component
• History of or known brain metastases
• Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Sunitinib + Gefitinib

Experimental group

Description:

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

Treatment:

Drug: Gefitinib + Sunitinib