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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00183833
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
* SWOG performance status 0-2.
* ANC greater than 1500, platelets greater than 100,000.
* Total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. Transaminase (AST and/or ALT) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis.
* Serum creatinine less than 1.25 x institutional upper limit of normal.
* Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
Exclusion Criteria:
* Patient has received any other investigational agent- within 28 days of first day of study drug dosing.
* Patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
* Patient has another severe and/or life-threatening medical disease.
* Patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
* Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by Novartis.
* Patient had a major surgery within 2 weeks prior to study entry.
* Patients with symptomatic brain metastasis.
* Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study)
* Medical, social or psychological factors interfering with compliance.
* Patients under therapeutic coumadin therapy.
* Patients under routine systemic corticosteroid therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00183833
Study Brief:
Protocol Section:
NCT00183833