Study of SU011248 in Patients With Advanced Kidney Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: SU011248 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254540

A6181072

Details and patient eligibility

About

To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).

Enrollment: 51 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven renal cell carcinoma with metastases with a component of clear cell histology

Exclusion criteria

• Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

SU-011248 capsule

Experimental group

Treatment:

Drug: SU011248 capsule