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 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT00816400
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed advanced solid tumor for which no curative or standard therapies exist
* Karnofsky performance status of ≥ 60
* Life expectancy of \>12 weeks
* Adequate hematologic and organ function
* Negative serum pregnancy test (women only)
* Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential
Exclusion Criteria:
* Prior chemotherapy or investigational treatment within 4 weeks of study drug administration
* Prior biological or immunological treatment within 6 weeks of study drug administration
* Concurrent therapy for of cancer
* Major surgery within four weeks or minor surgery within two weeks of study drug administration
* History of diabetes or current treatment for diabetes
* New York Heart Association ≥ Grade 2 congestive heart failure
* History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry
* History of other invasive malignancy within 5 years (exceptions are cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that are surgically cured)
* Significant active infection
* Known brain metastases
* Pregnancy or lactation or plans to become pregnant while on study
* Clinically significant abnormality on ECG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00816400
Study Brief:
Protocol Section:
NCT00816400