SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB VS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC

• Conditions: Adjuvant treatment of subjects with high risk” Renal Cell Carcinoma (RCC) following nephrectomy.; MedDRA version: 9.1Level: HLTClassification code 10038408Term: Renal cell carcinomas

• Registration Number: EUCTR2006-004024-37-AT
• Lead Sponsor: Pfizer Inc. - 235 East 42nd Street - New York - 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-23
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

1.Subjects must sign and date IRB/IEC-approved informed consent
2.Age = 18 years
3.ECOG Performance Status 0 – 2 prior to nephrectomy
4.Subjects must be diagnosed in the high risk UISS staging system with one of the following:
a.T3 N0 or Nx, M0, Fuhrman’s grade = 2 and ECOG general status = 1, or
b.T4 N0 or Nx, M0, any Fuhrman’s grade and any ECOG general status, or
c.Any T, N1-2, M0, any Fuhrman’s grade and any ECOG general status
5.Subjects must have histologically confirmed preponderant clear cell RCC
6.Subjects must have no evidence of macroscopic residual disease or metastatic disease Subjects having evidence for microscopic disease (R1) are acceptable
7.Subjects must not have received any specific medical previous systemic treatment for RCC
8.Subjects must not have received any previous anti-angiogenic treatment
9.Subjects must receive the first oral dose of sunitinib not more than 10 weeks after date of nephrectomy (see Appendix 6 for Nephrectomy Procedure).
10.Subjects must have adequate organ function defined as:
a.Platelets = 100 x 109/L, hemoglobin = 8 g/dl, absolute neutrophil count (ANC) =1.5 x 109/L;
b.Bilirubin =< 3 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 times the upper limit of normal
c. International Normalize Ratio (INR) =< 1.7 or Prothrombin time (PT) =< 6 sec over
d.Calculated creatinine clearance = 30 ml/min.
11.Sufficient left ventricular ejection function (LVEF) defined as =50% 3 to 10 weeks after date of nephrectomy based on 2-D echocardiogram (ECHO) or multigated acquisition MUGA
12.Women and men must use adequate contraception during the study. Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner or vasectomy.
13.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.Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
2.NCI CTCAE grade 3 hemorrhage <4 weeks of date of randomization.
3.Diagnosis of any second malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months.
4.Any of the following within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
5.Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing before 7 and 12 days before date of randomization (e.g., ketoconazole, rifampin, etc. respectively).
6.Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 500 msec.
7.Hypertension that cannot be controlled by medications.
8.Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin currently or within 2 weeks prior to first day of sunitinib administration. Low dose warfarin for deep vein thrombosis (DVT) prophylaxis is permitted (up to 2 mg/day). Low molecular weight heparin or aspirin are allowed.
9.Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
10.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
11.Known active hepatitis.
12.Pregnancy or breastfeeding. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to date of randomization.
13.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 subject inappropriate for entry into this study.
14.Receipt of any investigational oncology or, approved or investigational anti-angiogenic agent prior to study entry.
15.Current treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials, e.g. PRO methods studies, are allowed.

Study & Design

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