A clinical trial to study the effects Adjuvant Axitinib in patients at High Risk of Recurrent Renal Cell Carcinoma
- Conditions
- Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvisHealth Condition 2: null- Subjects at High Risk of Recurrent Renal Cell Carcinoma
- Registration Number
- CTRI/2012/09/002999
- Lead Sponsor
- SFJ Pharma Ltd II
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 592
1.Male or female, age more than or equal to 18 years (age more than or equal to 20 years in Japan).
2.Patients must be diagnosed utilizing the UISS staging system with one of the following:
a.T2 N0 or Nx, M0, Fuhrmanâ??s grade 3 to 4 (partial Fuhrmanâ??s grade 3 to 4 is also acceptable) and ECOG PS 0 to1
b.T3 N0 or Nx, M0, any Fuhrmanâ??s grade and ECOG PS 0 to 1
- T3a invasion to Gerota fascia; Tumor more than 4 cm in greatest dimension is eligible
c.T4 N0 or Nx, M0, any Fuhrmanâ??s grade and ECOG PS 0 to 1
d.Any T, N1, M0, any Fuhrmanâ??s grade and ECOG PS 0 to 1
3.Patients must have histologically confirmed preponderant, defined as more than 50%, clear cell RCC.
4.Patients must have no evidence of macroscopic residual disease or metastatic disease.
5.Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
6.Patients must not have received any previous anti-angiogenic treatment.
7. Patients must have adequate organ function defined as:
Absolute neutrophil count (ANC) more than or equal to 1500 cells per mm3.
Platelets more than or equal to 75,000 cells per mm3.
Hemoglobin (Hgb) more than or equal to 9.0 g per dL.
AST and ALT less than or equal to 2.5 multiplied by upper limit of normal (ULN).
Total bilirubin less than or equal to 1.5 multiplied by ULN.
Serum creatinine (Scr) less than or equal to 1.5 multiplied by ULN or calculated creatinine clearance (Clcr) more than or equal to 60mL per min by the Cockcroft-Gault equation, For males; the Cockcroft-Gault equation, using Scr: Clcr (mL per min) equal to (140 -Age in years) multiplied by weight (in kilograms) divided by {72 multiplied by Scr (in mg per dL)}).
The calculated Clcr should be multiplied by 0.85 to adjust for female gender.
•Urinary protein less than 2 by urine dipstick. If dipstick is more than or equal to 2 then a urine protein:urine creatinine ratio (UPC) should be done and the patient may enter only if UPC is less than 2.0.
8.At screening and Cycle 1 Day 1, no evidence of preexisting uncontrolled hypertension as documented by 2 blood pressure (BP) readings taken at least 1 hour apart. The systolic blood pressure (sBP) readings must be less than or equal to 140 mm Hg, and the diastolic blood pressure (dBP) readings must be less than or equal to 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
9.Women of childbearing potential 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.
10.Signed and dated informed consent document (ICD) indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
11.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Patients presenting with any of the following will not be included in the trial:
1.Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites.
2.National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage less than 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: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
5.Gastrointestinal abnormalities including:
inability to take oral medication
requirement for intravenous alimentation
prior surgical procedures affecting absorption including total gastric resection
treatment for active peptic ulcer disease in the past 6 months
active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis,
hematochezia or melena in the past 3 months without evidence of resolution
documented by endoscopy or colonoscopy
malabsorption syndromes
6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4/5 inhibitors (eg, grapefruit juice, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
7. Current use or anticipated need for treatment with drugs that are known CYP3A4/5 or CYP1A2 inducers (eg, rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and St. Johnâ??s wort).
8. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose warfarin (less than2mg/day) and other low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
9. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
10. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
11.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
12.Pregnancy or breastfeeding. All female patients of childbearing potential must have a negative pregnancy test within the 7 days prior to date of randomization.
13.Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
14.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.
15.Receipt of any investigational oncology or, approved or investigatio
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method