Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology MedDRA version: 7,1 Classification code 10038415
Conditions
Interventions
Product Code: su011248 L-malate salt
Pharmaceutical Form: Capsule, hard
Sponsors
PFIZER LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven renal cell carcinoma with metastases 2. Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST). 3. Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated with IFN-a alone must have received IFN-a for at least 4 weeks. 4. Male or female, 18 years of age or older. 5. ECOG performance status 0 or 1. 6. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade : less/equal to 1. 7. Adequate organ function as defined by the following criteria:· - Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less/equal to 2.5 x upper limit of normal (ULN), or AST and ALT less/equal 5 x ULN if liver function abnormalities are due to underlying malignancy· - Total serum bilirubin less/equal 1.5 x ULN - Absolute neutrophil count (ANC) major/equal to 1500/mL - Platelets major/equal to 100,000/mL - Hemoglobin major/equal to 8.0 g/dL without support of growth factors - Serum calcium less/equal 12.0 mg/dL - Serum creatinine less/equal 1.5 x ULN 8. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any systemic therapy other than 1 cytokine-based therapy. 2. Previous treatment on a SU011248 clinical trial. 3. Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment. 4. 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. 5. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan. 6. 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. 7. Ongoing cardiac dysrhythmias of grade major/equal to 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 8. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 9. Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). 10. Known human immunodeficiency virus (HIV) infection. 11. Current treatment on another therapeutic clinical trial. 12. Pregnancy or breastfeeding. Patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study treatment. 13. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the activity of SU011248 in cytokine-refractory metastatic RCC when administered in a continuous treatment regimen - To evaluate the safety and tolerability of SU011248 administered in a continuous treatment regimen - To evaluate the tolerability of SU011248 administered in the morning versus in the evening prior to sleep - To assess patient reported outcomes (PRO) - To determine SU011248 and SU012662 trough concentrations (Ctrough) for evaluation of steady-state pharmacokinetics -To explore the correlations of potential biomarkers with clinical outcomes ;Secondary Objective: ;Primary end point(s): Objective Response Rate (ORR) | — |
Countries
Germany, Sweden
Outcome results
None listed