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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00955292
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed solid tumors or lymphomas.
* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.
* One or more tumors measurable on radiograph or CT scan, or evaluable disease (e.g., malignant ascites).
* Karnofsky performance status of greater than or equal to 70.
* Life expectancy of at least 3 months.
* Age at least 18 years.
* Patients must have central IV access, or agree to the insertion of a central IV line.
* Normal oxygen saturation by pulse oximetry on room air
* A negative pregnancy test (if female).
* Acceptable liver function as evaluated by laboratory results
* Acceptable renal function as evaluated by laboratory results
* Acceptable hematologic status as evaluated by laboratory results
* No clinically significant urinalysis abnormalities
* Acceptable coagulation status as evaluated by laboratory results
* Fertile men and women must use effective contraceptive methods during the study.
Exclusion Criteria:
* Seizure disorders requiring anticonvulsant therapy.
* Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months).
* Severe chronic obstructive pulmonary disease with hypoxemia, or an uncorrectable pulmonary compromise.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Pregnant or nursing women.
* Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
* Unwillingness or inability to comply with procedures required in this protocol.
* Known infection with HIV, hepatitis B, or hepatitis C.
* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
* Patients who are currently receiving any other investigational agent.
* Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones, biological agent or formulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00955292
Study Brief:
Protocol Section:
NCT00955292