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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT00866320
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma with a component of clear cell histology
* Metastatic disease
* Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab
* Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab
* Measurable disease by RECIST criteria
* CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
* WBC ≥ 3,000/μL
* Absolute neutrophil count ≥ 1,500/μL
* Platelet count ≥ 75,000/μL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST/ALT ≤ 2.5 times ULN
* Creatinine ≤ 2.0 times ULN
* Negative pregnancy test
* No significant cardiovascular disease, including any of the following:
* Congestive heart failure (New York Heart Association class III-IV heart disease)
* Active angina pectoris requiring nitrate therapy
* Uncontrolled dysrhythmias
* Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered
* No prior sorafenib tosylate
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent prophylactic growth factors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00866320
Study Brief:
Protocol Section:
NCT00866320