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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00303732
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor with radiographic evidence of metastatic disease
* No standard therapy exists (phase I)
* Unresectable or metastatic renal cell carcinoma (phase Ib)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* AST or ALT ≤ 2.5 times upper limit of normal (ULN)
* Total cholesterol \< 300 mg/dL
* Triglycerides \< 350 mg/dL
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN OR creatinine clearance \> 40 mL/min
* Negative proteinuria by dip stick OR total urinary protein ≤ 500 mg
* No uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with antihypertensive regimen
* No unstable angina pectoris
* No symptomatic congestive heart failure (New York Heart Association class III or IV heart disease)
* No uncontrolled serious cardiac arrhythmia (symptomatic supraventricular tachycardia or any ventricular tachycardia/fibrillation)
* No myocardial infarction in the past 6 months
* No uncontrolled diabetes
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* No active or uncontrolled infection
* No uncontrolled hyperlipidemia
* No chronic renal disease
* No acute or chronic liver disease (e.g., hepatitis or cirrhosis)
* No impaired gastrointestinal (GI) function OR GI disease that may significantly alter the absorption of vatalanib or everolimus, including any of the following:
* Ulcerative disease
* Uncontrolled nausea and vomiting with solid food
* Watery diarrhea \> 5 times daily
* Malabsorption syndrome
* Bowel obstruction
* Inability to swallow the tablets
* No confirmed HIV infection
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent severe and/or uncontrolled medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
* Recovered from prior therapy
* No prior antivascular endothelial growth factor therapy
* More than 4 weeks since prior major surgery\* (laparotomy)
* More than 2 weeks since prior minor surgery\*
* More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
* More than 6 weeks since prior antibody therapy
* More than 2 weeks since prior biologic/immunotherapy
* More than 2 weeks since prior limited-field radiotherapy
* More than 4 weeks since prior full-field radiotherapy
* More than 4 weeks since prior investigational agents
* Prior transfusions allowed provided blood counts are stable for \> 2 weeks
* Concurrent epoetin alfa allowed
* No concurrent warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system
* Heparin and low molecular weight heparin allowed NOTE: \*Insertion of a vascular access device is not considered major or minor surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00303732
Study Brief:
Protocol Section:
NCT00303732