Phase 2
Completed N=107
Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
Source: ClinicalTrials.gov NCT00137423 ↗Enrolled (actual)
107
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects — 15; 6 participants
Summary
To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects |
15; 6 | — |
| SECONDARY Duration of Tumor Response |
24.0; 32.0 | — |
| SECONDARY Time to Tumor Progression (TTP) |
35.7; 35.9 | — |
| SECONDARY Progression Free Survival (PFS) |
35.7; 35.3 | — |
| SECONDARY Overall Survival |
91.4; 76.4 | — |
| SECONDARY Summary of FACIT Fatigue Scale Overall Score |
39.5; 39.6; 43.4; 42.7; 28.0; 29.4 | — |
| SECONDARY Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index |
0.0; 0.0; 0.0; -0.1 | — |
| SECONDARY Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score |
0.0; 0.0; -10.0; -9.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00137423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.