Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sunitinib malate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00338884

A6181110

Details and patient eligibility

About

A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced kidney cancer

Exclusion criteria

• Previous treatment for kidney cancer, except surgical removal of kidney tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

SUNITINIB MALATE.

Experimental group

Description:

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Treatment:

Drug: Sunitinib malate