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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01049620
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction
* No history of chemotherapy or radiation
* Age 18 to 70 years old
* Estimated life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow function (white blood cell counts \>3,000/uL, absolute neutrophil count\>1,500/uL, Platelets\>100,000/uL, Hgb\>8 g/dL)
* Adequate kidney function (creatinine\<1.5 mg/dL)
* Adequate liver function (bilirubin\<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \<3 times the upper normal limit (5 times for patients with liver metastasis))
* Signed written informed consent
Exclusion Criteria:
* Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
* Presence of central nervous system metastasis
* Bowel obstruction
* Evidence of serious gastrointestinal bleeding
* Peripheral neuropathy (NCI CTC AE version 3.0 \> Grade I)
* History of significant neurologic or psychiatric disorders
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Other serious illness or medical conditions
* Patients with known history of ischemic heart disease and/or with myocardial infarction
* Known allergy to study drugs
* Administration of drugs showing interaction with RAD001
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01049620
Study Brief:
Protocol Section:
NCT01049620