Renal Cell Carcinoma MedDRA version: 16.1 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified System Organ Class: 100000004864
Conditions
Interventions
Product Name: Axitinib
Pharmaceutical Form: Tablet
INN or Proposed INN: AXITINIB
CAS Number: 319460-85-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmace
Sponsors
SFJ Pharma Ltd. II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have no evidence of macroscopic residual disease or metastatic disease. 2. Male or female, age ?18 years (age ?20 years in Japan, Korea and Taiwan, age ?18 years and ? 65 years in India). 3. Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 29, Eastern Collaborative Oncology Group (ECOG) performance status (PS). Any Fuhrman grades are eligible. The patient subgroups will be as follows: a. pT2, pN0 or pNx, M0 and ECOG PS 0-1 b. pT3, pN0 or pNx, M0 and ECOG PS 0-1 c. pT4, pN0 or pNx, M0 and ECOG PS 0-1 d. Any pT, pN1, M0 and ECOG PS 0-1 4. Patients must have histologically confirmed preponderant, defined as >50%, clear cell RCC. 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) ?1500 cells/mm3. ? Platelets ?75,000 cells/mm3. ? Hemoglobin (Hgb) ?9.0 g/dL. ? AST and ALT ?2.5 x upper limit of normal (ULN). ? Total bilirubin ?1.5 x ULN. ? Serum creatinine (Scr) ?1.5 x ULN or calculated creatinine clearance (Clcr) ?60 mL/min (by the Cockcroft-Gault equation*). * For males; the Cockcroft-Gault equation, using Scr : Clcr (mL/min) = (140 - Age in years) × weight (in kilograms) / [72 × Scr (in mg/dL)] The calculated Clcr should be multiplied by 0.85 to adjust for female gender. ? Urinary protein =65 years) yes F.1.3.1 Number of subjects for this age range 296
Exclusion criteria
Exclusion criteria: 1. Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites. 2. Active bleeding (other than menstrual bleeding) at randomization. 3. Diagnosis of any non-RCC 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 ? chronic diarrhea that persists at Grade 3 or 4 despite maximal medical therapy 6. Major surgery <4 weeks, or radiation theapy <2 weeks, of starting the study treatment or incomplete healing of surgical or superficial wounds. 7. 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). 8. 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. John?s wort). 9. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose warfarin 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. 10. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis. 11. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment. 12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 13. Pregnancy or breastfeeding. Urinary pregnancy test should be performed by sites on female patients who have not experienced at least one consecutive year of amenorrhea without ovarian dysfunction, or have been taking hormonal therapy, or have been rendered surgically sterile. If positive, serum pregnancy test should be performed at central laboratories. All female patients of childbearing potential must have a negative pregnancy test within the 14 days prior to date of randomization. (Definition of surgical sterilization: patients who underwent hysterectomy or bilateral oophorectomy, or bilateral tubal ligation) 14. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 15. Other severe acute or chronic medical or psychiatri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate an improvement in disease free survival (DFS) in patients at high risk of recurrent RCC randomly assigned to adjuvant axitinib (Arm A) vs. Placebo (Arm B) after nephrectomy.;Secondary Objective: ? Compare overall survival (OS) associated with Arm A to that associated with Arm B ? Assess safety/toxicity profile of administration of axitinib;Timepoint(s) of evaluation of this end point: Throughout the duration of the study;Primary end point(s): DFS, defined as the time interval from the date of randomization to the first date of recurrence (distant or local recurrence of RCC) or the occurrence of a secondary malignancy (occurrence of a second primary cancer other than RCC except basal cell carcinoma, squamous cell skin cancer or in situ carcinoma of the cervix uteri) or death. The primary DFS analysis will be based on the imaging assessment by the IRC with pathology confirmed at the investigator?s discretion at site (local review). Recurrence refers to relapse of the primary tumor in situ or at metastatic sites. The date of recurrence or the occurrence of a secondary malignancy is defined as the date of the tumor scan that demonstrated unequivocal recurrence or a second malignancy according to protocol criteria (not the date of IRC review, and not the date of the biopsy). For patients with no DFS event, DFS time will be censored at the date of last disease assessment (last scan prior to the time for final analysis. Patients alive who do not have post-baseline disease assessment will have their DFS times censored at randomization. For patients receiving further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS will be censored on the date of the last tumor assessment (last scan) prior to taking the anti-tumor medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS, defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive. Patients lacking data beyond randomization will have their survival times censored at randomization.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Countries
Spain
Contacts
Public ContactRSU-RA
Quintiles Limited
Outcome results
None listed