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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT00390806
Eligibility Criteria:
Inclusion criteria:
* At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
* Must have received previous chemotherapy
* Must be 18 years of age of greater
* Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2
* At least 2 weeks must have elapsed since any surgery
* At least 4 weeks must have elapsed since any radiation to a non-CNS site
* Must have adequate bone marrow, renal, and live capacities
* Women must be of non-childbearing potential or practice adequate birth control
* Males must practice adequate methods of birth control
* Must sign written informed consent
Exclusion criteria:
* Previous whole brain radiation therapy
* Prior treatment with topotecan
* Investigational agent within 30 days or 5 half-live
* Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib
* Primary or secondary immunodeficiencies
* Gastrointestinal conditions that affect GI absorption or motility
* Uncontrolled emesis
* Brain metastasis at time of initial diagnosis of NSCLC
* History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
* Pregnant or intending to become pregnant or intending to father a baby
* Any severe concurrent medical condition that could affect compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00390806
Study Brief:
Protocol Section:
NCT00390806