Carcinoma, Renal Cell Metastasis Clinical Trial
Official title:
A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
| Verified date | September 2009 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
| Status | Completed |
| Enrollment | 107 |
| Est. completion date | May 2008 |
| Est. primary completion date | September 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Pfizer Investigational Site | Villejuif | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Greece | Pfizer Investigational Site | Thessaloniki | |
| Netherlands | Pfizer Investigational Site | Nijmegen | Gld |
| Sweden | Pfizer Investigational Site | Lund | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Switzerland | Pfizer Investigational Site | St. Gallen | |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, France, Germany, Greece, Netherlands, Sweden, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up | No | |
| Secondary | Duration of Tumor Response | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up | No | |
| Secondary | Time to Tumor Progression (TTP) | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up | No | |
| Secondary | Progression Free Survival (PFS) | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up | No | |
| Secondary | Overall Survival | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up | No | |
| Secondary | Summary of FACIT Fatigue Scale Overall Score | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. | No | |
| Secondary | Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. | No | |
| Secondary | Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. | No |