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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT00742261
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of solid tumor malignancy.
* 18 years old with ECOG of 0-1.
* female subject who is not pregnant
* Male subjects must agree to use contraception methods
* Able to swallow and retain oral medication.
* The subject will refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
* QTcB or QTcF \< 470 msec.
* Bilirubin = 1.5mg/dl, AST, ALT, ALP \<2X ULN in absence of malignant disease in the liver or \<5X ULN in case of liver involvement by the tumor.
* Serum Creatinine \<1.5mg/dL
Exclusion Inclusion:
* The subject has received anticancer treatment.
* The subject has participated in a clinical trial and has received an investigational product within 21 days.
* The subject has known brain metastases.
* The subject has uncontrolled intercurrent illness.
* History of sensitivity to any of the study medications, or components.
* The subject is known to be positive for the human immunodeficiency virus (HIV).
* Subjects who have had partial or complete gastrectomy.
* Pregnant females as determined by positive ß-hCG test at screening or prior to dosing.
* Lactating females.
* Unwillingness or inability to follow the procedures outlined in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00742261
Study Brief:
Protocol Section:
NCT00742261