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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00363194
Eligibility Criteria:
Inclusion criteria:
* Histologically or cytologically confirmed diagnosis of advanced solid tumors that have progressed following treatment with standard agents. Patients may have either measurable disease by RECIST or may be followed by a tumor marker for assessment of disease.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate bone marrow function: ANC greater than or equal to 1,500 mm cubed; Platelets count greater than or equal to 100,000 mm cubed; Hgb greater than or equal to 9 g per dL
* Adequate renal function as determined by a creatinine clearance greater than 50mL per min calculated by the Cockcroft-Gault Formula; Measured creatinine clearance greater than or equal to 50mL per min by 24-hour urine collection will be acceptable in lieu of a calculated value.
* Urine Creatinine Ratio of less than 1 as assessed in a random or spot urine sample.
* Adequate hepatic function: total bilirubin less than or equal to 1.5 times the upper limit of normal; AST and ALT less than or equal to 2.5 times the upper limit of normal.
* PT, INR, PTT less than or equal to 1.2 times upper limit of normal.
* Male or female at least 18 years of age.
* A woman is eligible to enter and participate in the study if she is of: Non-childbearing potential; Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception per protocol. A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study. If sexually active, patients will continue the recommended contraceptive measures for the duration of the treatment and for 28 days following discontinuation of therapy.
* Predicted life expectancy of at least 12 weeks.
* Written informed consent.
* Able to swallow and retain oral medications.
Exclusion criteria:
* Patients with certain heart problems or history of bleeding within a month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00363194
Study Brief:
Protocol Section:
NCT00363194