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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT01248403
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥ 18 years old
* Histologically or cytologically confirmed and documented gastric adenocarcinoma. Adenocarcinomata of the gastro-esophageal junction will be allowed, if they have advanced disease (inoperable, recurrent or metastatic disease).
* Documented progressive disease during/after one, two or three prior treatments containing 5FU and/or its precursors or derivatives in the palliative setting
* At least one measurable or evaluable lesion by RECIST as determined by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI)
* ECOG performance status of 0, 1 or 2
* The following laboratory parameters:
* Absolute neutrophil count ≥ 1.5 x 109/L
* Platelets ≥ 100 x 109/L
* Hemoglobin (Hgb) ≥ 9 g/dL
* Serum creatinine ≤ 2 x Upper Limit of Normal (ULN)
* Adequate liver function:
* Total serum calcium (corrected for serum albumin) or ionized calcium ≥ LLN
* Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatments and must be willing to use adequate methods of contraception during the study and for 3 months after last study drug administration.
* Written informed consent
Exclusion Criteria:
* Current treatment with any anti cancer therapy or treatment with anti cancer therapy ≤ 2 weeks prior to study treatment start unless rapidly progressing disease is measured
* Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g. sirolimus, temsirolimus)
* Known prior history of hypersensitivity to paclitaxel.
* Paclitaxel refractory disease, which is defined as a disease progression under or within 12 weeks of last taxan treatment
* Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent
* Major surgery ≤ 2 weeks prior to starting study treatment or patients who have not recovered from such therapy
* Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade \<= 1. Note: Neuropathy due to prior chemotherapy is allowed.
* Unstable CNS disease
* Requiring increasing doses of steroids to maintain stable neurological status
* Deteriorating / changing neurological status
* Known history of HIV seropositivity (HIV testing is not mandatory) or Hepatitis B or C.
* Active, bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin, as long as the INR is \<= 2.0)
* Any other severe and/or uncontrolled medical conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01248403
Study Brief:
Protocol Section:
NCT01248403