A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 ADMINISTERED IN A CONTINUOUS DAILY REGIMEN IN PATIENTS WITH CYTOKINE-REFRACTORY METASTATIC RENAL CELL CARCINOMA

• Conditions: Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology; MedDRA version: 7,1Classification code 10038415

• Registration Number: EUCTR2005-001270-27-SE
• Lead Sponsor: PFIZER LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the activity of SU011248 in cytokine-refractory metastatic RCC when administered in a continuous treatment regimen<br>- To evaluate the safety and tolerability of SU011248 administered in a continuous treatment regimen<br>- To evaluate the tolerability of SU011248 administered in the morning versus in the evening prior to sleep<br>- To assess patient reported outcomes (PRO)<br>- To determine SU011248 and SU012662 trough concentrations (Ctrough) for evaluation of steady-state pharmacokinetics<br>-To explore the correlations of potential biomarkers with clinical outcomes<br>;Secondary Objective: ;Primary end point(s): Objective Response Rate (ORR)