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 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT02489695
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Metastatic or locally advanced (inoperable) pure type 1 or 2 or mixed PRCC, histologically confirmed by central review: relevant slides \[and blocks if available\] with the initial histology report must be sent for central reading before confirmation of inclusion.
3. No prior systemic treatment for metastatic renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation).
4. At least one measurable site of disease as defined by RECIST 1.1 criteria.
5. ECOG performance status of 0, 1.
6. No toxicity \> 1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
7. In case of prior radiation therapy, discontinuation of irradiation for at least 4 weeks before first dose of study treatment. This period can be reduced to at least 1 week in case of radiotherapy in a limited field (\< 10% of the whole body) while no side effects grade ≥ 2 is expected and keeping at least one site for evaluation.
8. Adequate bone marrow, liver and renal function, as defined below:
* Absolute neutrophil count ≥ 1.5 G/L, platelet count ≥ 100 G/L, and hemoglobin ≥ 9 g/dL),
* AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) and total bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN if liver metastases),
* Serum creatinine ≤ 2.0 x ULN or creatinine clearance ≥ 50 mL/min according to Cockroft formula or MDRD formula for patients older than 65 years,
9. Absence of proteinuria confirmed by urinary dipstick test. If the dipstick test is ≥ 2+, proteinuria will be quantitated on a complete 24h urine sample (\< 1 g/L of protein/24h sample).
10. Adequate contraceptive methods for fertile female subjects for the whole duration of the study and for 7 days after the last dose of study drug.
Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.
11. Covered by a medical insurance, in countries where applicable.
12. Written informed consent before any study specific procedures or assessments.
Exclusion Criteria:
1. Prior TKI treatment in adjuvant situation for renal cancer.
2. Significant cardiovascular disease including:
* Disorder of left ventricular function with a LVEF \< 50%,
* Uncontrolled arterial hypertension under adapted medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg or both despite appropriate therapy, or patients under 3 antihypertensive therapies at screening,
* Myocardial infarction, severe angina, or unstable angina within 6 months prior to inclusion,
* History of serious ventricular arrhythmia (ie ventricular tachycardia or ventricular fibrillation),
* Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication),
* Coronary or peripheral artery bypass graft within 6 months of screening.
3. Presence of brain metastases on MRI or CT-scan performed within 28 days prior to inclusion. Patients with a history of brain metastases treated by surgery or stereotactic surgery, with normal brain MRI or CT-scan are allowed to participate.
4. Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.
5. Any active acute or chronic or uncontrolled infection/disorder that impair the ability to evaluate the patient or the ability for the patient to complete the study.
6. Prior history of other malignancies other than PRCC (except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix) unless the subjects has been free of the disease for at least 3 years.
7. Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
8. Patient included in another clinical trial, except for supportive care trials.
9. Psychological, familial, sociological, or geographical conditions that would limit compliance with study protocol requirements.
10. Pregnant or breastfeeding women (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02489695
Study Brief:
Protocol Section:
NCT02489695