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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT00541359
Eligibility Criteria:
Inclusion
* Histologic proof of solid tumor malignancy
* ANC \>= 1500/microliter
* PLT \>= 150,000/microliter
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* AST =\< 2.5 x ULN or AST =\< 5 x ULN if liver involvement
* Serum creatinine =\< 1.5
* Life expectancy \>= 12 weeks
* ECOG performance status 0, 1, or 2
* Subjects with asymptomatic brain metastases are allowed
Exclusion
* ECOG PS 3 or 4
* Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients must not have received chemotherapy or radiation therapy for at least four weeks, and they must have recovered from any toxicities of previous treatment (ongoing grade 1 dermatologic toxicities are allowable)
* Eligible patients should not be taking enzyme-inducing anticonvulsants due to the potential of pharmacokinetic interactions
* Pregnant and nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\] or abstinence, etc.)
* Other concurrent chemotherapy, immunotherapy, or radiotherapy
* HIV-positive patients receiving anti-retroviral therapy (HAART); there is a potential for pharmacokinetic interactions
* Bisphosphonate therapy (e.g. pamidronate or zoledronate) will not be considered investigational agents for the purpose of trial eligibility
* Pre-existing grade \>= 2 neuropathy
* No previous treatment with PS-341 allowed, however there is no limit to other prior therapy with chemotherapy, including topotecan, and radiation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00541359
Study Brief:
Protocol Section:
NCT00541359