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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00834704
Eligibility Criteria:
Inclusion Criteria:
* Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
* Patients who have experienced disease progression after receiving appropriate standard / approved chemotherapy and for whom no further standard or palliative treatment measures exist, or who have chosen to decline standard or palliative treatment.
* One or more tumors measurable by RECIST criteria.
* Karnofsky performance status ≥ 70%.
* Recovery from any toxic or other effects of all previous therapy, including radiation, chemotherapy and surgery.
* Negative serum or urine pregnancy test result in women of childbearing potential.
* For men and women of child-producing potential, agreement to use effective contraception (hormonal or barrier birth control or abstinence) from the time of screening before study entry and throughout study participation.
Exclusion Criteria:
* Brain metastasis.
* New York Heart Association Class III or IV cardiac disease, myocardial infarction, or cardiac arrhythmia requiring medical therapy.
* Known allergy to hyaluronidase.
* Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions including psychiatric illness) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
* Women currently breast feeding.
* Concurrent participation in any other interventional therapeutic study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00834704
Study Brief:
Protocol Section:
NCT00834704