Know Cancer

forgot password

A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell Metastasis

Thank you

Trial Information

A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Inclusion Criteria:

- Histologically proven renal cell carcinoma with metastases.

- Evidence of unidimensionally measurable disease as per Response Evaluation Criteria
in Solid Tumors (RECIST).

- Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated
with IFN-á alone must have received IFN-á for at least 4 weeks.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

- Resolution of all acute toxic effects of prior therapy or surgical procedures to
grade 1.

- Adequate organ function

Exclusion Criteria:

- Prior treatment with any systemic therapy other than 1 cytokine-based therapy.

- Previous treatment on a SU011248 (sunitinib) clinical trial.

- Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the
study treatment.

- Diagnosis of any second malignancy within the last 3 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately
treated with no evidence of recurrent disease for 12 months.

- History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease on screening Computed
Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.

- Any of the following within the 12 months prior to starting the study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, cerebrovascular accident or transient ischemic
attack, or pulmonary embolism.

- Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc
interval >450 msec for males or >470 msec for females.

- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
medical therapy).

- Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up
to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).

- Known human immunodeficiency virus (HIV) infection.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects

Outcome Time Frame:

4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

May 2008

Related Keywords:

  • Carcinoma, Renal Cell Metastasis
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Las Vegas, Nevada  89128