A Phase 3, Randomized Study of SU011248 versus Interferon-a as First-Line Systemic Therapy for Patients with Metastatic Renal Cell Carcinoma

Phase 1

• Conditions: Renal Cell Carcinoma; MedDRA version: 9.1 Level: HLT Classification code 10038408 Term: Renal cell carcinomas

• Registration Number: EUCTR2004-001149-14-GB
• Lead Sponsor: Pfizer Inc. - 235 East 42nd Street - New York - 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-03
• Study Completion: 2008-09-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 690

Inclusion Criteria

1. Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology.
2. Evidence of unidimensionally measurable disease (ie, =1 malignant tumor mass that can be accurately measured in at least 1 dimension =20 mm with conventional CT or MRI scan, or =10 mm with spiral CT scan [if spiral CT scan is used, minimum lesion size should be twice the reconstruction interval used, eg, if reconstruction size is 7 mm, lesion size should be =14 mm]). Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
3. Male or female, 18 years of age or older.
4. ECOG performance status 0 or 1.
5. Resolution of all acute toxic effects of prior radiotherapy or surgical procedure to NCI
CTCAE Version 3.0 grade =1.
6. 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]) =2.5 x central laboratory upper limit of normal (CL-ULN), or AST and ALT =5 x
CL-ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin =1.5 x CL-ULN
• Absolute neutrophil count (ANC) =1500/µL
• Platelets =100,000/µL
• Hemoglobin =9.0 g/dL
• Serum calcium =12.0 mg/dL
• Serum creatinine =1.5 x CL-ULN
• Prothrombin time (PT) =1.5 x CL-ULN
• Left ventricular ejection fraction (LVEF) = lower limit of normal (LLN) as defined by the institution performing the scan as assessed by multigated acquisition (MUGA) scan
7. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
8. 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Renal cell carcinoma without any clear (conventional) cell component.
2. Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC (including immunotherapy, chemotherapy, hormonal, or investigational therapy).
3. Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
4. NCI CTCAE grade 3 hemorrhage <4 weeks of starting the study treatment.
5. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
6. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening CT or MRI scan.
7. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
8. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
9. Ongoing cardiac dysrhythmias of NCI CTCAE grade =2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
10. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
11. Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
13. Current treatment on another clinical trial.
14. Pregnancy or breastfeeding. Female patients must be surgically sterile or 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 enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
15. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Study & Design

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