AG-013736 (axitinib) for the treatment of metastatic renal cell cancer (mRCC) - Specific for Bulgaria only
- Conditions
- metastatic renal cell cancerMedDRA version: 15.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-018585-23-BG
- Lead Sponsor
- Pfizer Inc 235 East 42nd Street, New York, NY10017
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 447
1. Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype with metastasis.
2. Evidence of unidimensionally measurable disease per RECIST (ie, =1 malignant tumor mass that can be accurately measured in at least 1 dimension = 20 mm with conventional computerized tomography [CT] scan or Magnetic Resonance Imaging [MRI], or =10 mm with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm). 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. Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first-line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
4. Patients may have received prior adjuvant therapy with interferon and/or interleukin if recurrence occurred > 6 months after the last dose of adjuvant therapy.
5. Adequate organ function as defined by the following criteria:
•Absolute neutrophil count (ANC) =1500 cells/mm3;
•Platelets =75,000 cells/mm3.
•Hemoglobin =9.0 g/dL.
•AST and ALT =2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT =5.0 x ULN;
•Total bilirubin =1.5 x ULN;
•Serum creatinine =1.5 x ULN or calculated creatinine clearance =60 mL/min;
•Urinary protein <2+ by urine dipstick. If dipstick is =2+ then a 24-hour urine
collection can be done and the patient may enter only if urinary protein is <2 g per24 hours.
6. Male or female, age =18 years.
7. ECOG performance status of 0 or 1.
8. Life expectancy of =12 weeks.
9. At least 2 weeks since the end of prior systemic treatment, radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 3.0 grade =1 or back to baseline except for alopecia or hypothyroidism.
10. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be =140 mm Hg, and the baseline diastolic blood pressure readings must be =90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
11. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
12. 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.
13. Willingness and ability to comply with scheduled visits, treatment plans (including
willingness to take either AG-013736 or sorafenib according to randomization),
laboratory tests, and other study procedures, including completion of patient reported outcome measures (FKSI and EQ-5D questionnaires).
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
1. Prior treatment of mRCC with more than one systemic first-line regimen.
2. Patients treated with any neoadjuvant or adjuvant systemic therapy < 6 months prior to screening.
3. Major surgery <4 weeks or radiation therapy <2 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. 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.
5. Current use or anticipated need for treatment with drugs that are known potent
CYP3A4/5 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, nefazodone,
itraconazole, miconazole, erythromycin, telithromycin, clarithromycin, indinavir,
saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and
delavirdine).
6. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole,
phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John’s wort).
7. Requirement of anticoagulant therapy with oral vitamin K antagonists. 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.
8. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
9. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
10. 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.
11. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
12. History of a malignancy (other than renal cell cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
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. Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth
control/contraception to prevent pregnancy during treatment and for 6 months after
discontinuing study treatment The definition of effective contraception should be in
agreement with local regulation and based on the judgment of the principal investigator or a designated associate.
15. Other severe acute or chronic medical or psychiatric condition or laboratory abnor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ? Compare the progression-free survival (PFS) of treatment-naïve patients with mRCC receiving AG-013736 vs sorafenib.<br>? Estimate the progression-free survival (PFS) of previously-treated Asian patients with mRCC receiving AG-013736 vs sorafenib.;Secondary Objective: Compare the OS of patients in each arm;<br>Compare the ORR of patients in each arm;<br>Evaluate the safety and tolerability of AG-013736;<br>Estimate the DR of patients in each arm;<br>Compare the kidney specific symptoms, and health status of patients in each arm as<br>measured by the FKSI, and EQ-5D.;Primary end point(s): Progression Free Survival (PFS)
- Secondary Outcome Measures
Name Time Method