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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT01404104
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old and capable of giving informed consent.
* Patient has radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T4, or any stage T with N1/2 and/or metastatic disease.
* Patient is already having a nephrectomy.
* Adequate cardiac function as assessed by electrocardiogram (ECG).
* Patient is will to have a kidney biopsy at baseline/screening.
* Patient has scored a 0 or 1 on the ECOG.
* Patient is negative for HIV, Hepatitis B, Hepatitis C
* If patient is a woman of child-bearing potential, they have to have a negative pregnancy test.
Exclusion Criteria:
* Patient has stage T1 disease without metastases.
* Patient has abnormal laboratory values at screening within the following ranges:
* Absolute neutrophil count ≤1.5 x 10(9)/L; Platelet count ≤ 100 x 10(9)/L
* Leukocyte count ≤ 3 x 10(9)/L; Hemoglobin ≤ 80 g/L
* Serum creatinine ≥ 2.0 x the upper normal limit (UNL)
* Total bilirubin ≤ 1.5 x UNL; AST and ALT ≤ 3.0 x UNL
* Fasting serum cholesterol ≤ 9.0 mmol/L
* Fasting serum triglycerides ≤ 5.0 mmol/L
* Patients with a known hyper-sensitivity to Temsirolimus.
* Other currently active malignancies.
* Currently taking any medications known to interfere with the metabolism of Temsirolimus.
* Patients receiving anticoagulation with warfarin.
* Patients with a history of pulmonary hypertension or interstitial lung disease.
* Unstable angina as judged by the primary investigator, or any recent MI in the last 180 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01404104
Study Brief:
Protocol Section:
NCT01404104