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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00637702
Eligibility Criteria:
Key Inclusion Criteria:
* Histological or cytological evidence of malignancy.
* Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
* Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Additional criteria exist.
Key Exclusion Criteria:
* Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
* Use of an investigational medication or device within 30 days prior to first dose of study drug.
* Major surgery within 30 days prior to first dose of study drug.
* Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
* Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
* Pregnancy or lactation.
* Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
* Additional criteria exist.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00637702
Study Brief:
Protocol Section:
NCT00637702