Phase 3 study of sunitinib versus placebo in subjects at high risk of recurrent kindey cancer

Phase 1

• Conditions: Adjuvant treatment of subjects with high risk” Renal Cell Carcinoma (RCC) following nephrectomy.; MedDRA version: 11.0Level: HLTClassification code 10038408Term: Renal cell carcinomasSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-004024-37-SE
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-28
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 619

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 utilizing the UISS staging system with one of the following:
a.T3 N0 or Nx, M0, any Fuhrman’s grade and any ECOG general status; 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, defined as >50%, clear cell RCC;
6.Subjects must have no evidence of macroscopic residual disease or metastatic disease. Subjects having evidenceof microscopic disease (Histological classification of R1 disease) are acceptable;
7.Subjects must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) 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 12 weeks after date of nephrectomy
10.Subjects must have adequate organ function defined as:
a.Platelets =75 x 109/L, hemoglobin = 8 g/dl, absolute neutrophil count (ANC) =1.5 x 109/L;
b.Bilirubin =3 mg/dL (known Gilbert’s exempt from this criteria), aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 times the upper limit of normal (ULN);
c.Calculated creatinine clearance =30 ml/min post-nephrectomy as determined by the Cockcroft and Gault Equation (listed in the Q&A document posted to the Insight space for all PCO managers);
11.Women and men must use adequate contraception during the study. Acceptable contraception for women include implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for a male includes having had a vasectomy for at least 6 months, sexual abstinence, or condoms plus spermicide;
12.UK and IRELAND ONLY. Women and men must use adequate contraception during the study. Adequate contraception is defined as double barrier contraception (ie, condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device).
13.Left ventricular ejection fraction (LVEF) = the lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO);
14.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 427
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 192

Exclusion Criteria

1.Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or subjects with any 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 6 months prior to study drug administration: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism;
5.Concurrent medication with known CYP3A4 inducers and potent inhibitors dosed 7 and 12 days before date of randomization, respectively
6.Ongoing cardiac dysrhythmias of NCI CTCAE Grade =2 or prolongation of the QTc interval to >500 msec;
7.Hypertension, defined as systolic >150 and/or diastolic >100, that cannot be controlled by medications;
8.Treatment with >2 mg of warfarin within 2 weeks prior to first day or concurrently with sunitinib administration is not recommended. Low dose warfarin for deep vein thrombosis (DVT) prophylaxis is permitted (<2 mg/day). Low molecular weight heparin (fractionated) or aspirin are allowed;
9.Any illness that may affect absorption, including but not limited to: inability to swallow oral medications, presence of active inflammatory bowel disease, partial or complete bowel obstruction, partial or complete gastrectomy, significant bowel resection, or chronic diarrhea;
10.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness;
11.Known active or chronic active hepatitis (Hepatitis B or C);
12.Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outline in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product;
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, eg, PRO methods studies, are allowed.
16. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

Study & Design

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