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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00798720
Eligibility Criteria:
Inclusion Criteria:
* Pathologically/histologically confirmed NSCLC
* Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)
* Measurable disease
* Two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy
* Prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy)
* ECOG performance status 0, 1, or 2
* Patients with brain metastases are allowed, if clinically stable after treatment
* Normal liver, kidney, and marrow function
* 18 years of age or older
* Negative pregnancy test for women of child-bearing potential.
* Life expectancy 3 months or more
* No concurrent use of other antitumor agents
Exclusion Criteria:
* Prior therapy with vorinostat, HDAC inhibitors, or bortezomib
* Pre-existing neuropathy grade \>/= 2
* Myocardial infarction within 6 months prior to enrollment or have NY Heart Association Class III or Class IV heart failure
* Have taken valproic acid \</= 4 weeks prior to enrollment
* Previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
* Hypersensitivity to bortezomib, boron, or mannitol
* Serious medical or psychiatric illness likely to interfere with participation in the clinical study
* Pregnant women
* HIV positive patients
* Hepatitis infection (HCV or HBV) patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00798720
Study Brief:
Protocol Section:
NCT00798720