Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT02122003
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Patients with histological diagnosis of Renal Cell Carcinoma (RCC)
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 12 weeks.
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
* Hemoglobin \>= 10.0 g/dl
* Absolute neutrophil count (ANC) \>1,500/mm3
* Platelet count \>= 100,000/ml
* Total bilirubin ≤ 1.5 times the upper limit of normal
* ALT and AST ≤ 2.5 x upper limit of normal
* Alkaline phosphatase ≤ 4 x upper limit of normal
* prothrombin time-international normalized ratio /partial thromboplastin time ≤ 1.5 x upper limit of normal \[Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.\] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until international normalized ratio is stable based on a measurement at pre-dose, as defined by the local standard of care.
* Prognosis according to Heng: good or intermediate
* Previous treatment with pazopanib
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
* Signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria:
* First line treatment for metastatic RCC other than pazopanib.
* History of cardiac disease: congestive heart failure \>New York Heart Association class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (\>= 160 mmHg systolic and/or 90 mmHg diastolic).
* History of HIV infection
* Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
* Brain or meningeal metastases
* Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
* History of organ allograft
* Patients with evidence or history of bleeding diathesis
* Patients undergoing renal dialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02122003
Study Brief:
Protocol Section:
NCT02122003