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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01024205
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma
* Measurable metastatic disease on CT/MRI imaging
* Patients with suspicion of renal cancer on radiology must have a biopsy to confirm diagnosis of clear cell disease
* No prior therapy for renal cancer
* Judged by the treating physician to have the potential to derive clinical benefit from this treatment
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1 x 10\^9/L (without growth factor support)
* Platelet count ≥ 75 x 10\^9/L
* Total bilirubin ≤ 2 times upper limit of normal (ULN) (except for patients with Gilbert disease)
* Serum creatinine ≤ 2 times ULN
* Serum transaminases \< 5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy
* Willing and able to comply with scheduled visits, treatment plan, and laboratory tests and other study procedures
* No congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 6 months, or ongoing severe or unstable arrhythmia requiring medication
* No other severe acute or chronic medical or psychiatric condition, or abnormal laboratory results that would impart, in the judgement of the investigator, excess risk associated with study participation or study drug administration or would make the patient inappropriate for entry into this study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 7 days since prior and no concurrent potent CYP3A inhibitors, including any of the following:
* Ketoconazole
* Itraconazole
* Clarithromycin
* Erythromycin
* Diltiazem
* Verapamil
* Delavirdine
* Indinavir
* Saquinavir
* Ritonavir
* Atazanavir
* Nelfinavir
* At least 12 days since prior and no concurrent potent CYP3A inducers, including any of the following:
* Rifampin
* Rifabutin
* Carbamazepine
* Phenobarbital
* Phenytoin
* St. John's wort
* Efavirenz
* Tipranavir
* Concurrent radiotherapy allowed provided sunitinib malate is stopped one day before and resumed one day after radiotherapy
* Concurrent coumarin-derivative anticoagulants (e.g., warfarin) allowed (≤ 2 mg/day) for prophylaxis of thrombosis
* No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide)
* No other concurrent investigational drug or participation in another clinical trial (unless approved by the sponsor)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01024205
Study Brief:
Protocol Section:
NCT01024205