Clinical trial: RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression (NCT01482299)

Eligibility criteria:
Inclusion Criteria:

          -  histologically or cytologically documented stomach adenocarcinoma including
             adenocarcinoma of the esophagogastric junction

          -  non-resectable disease by metastasis or recurrent disease after curative surgical
             resection (See Appendix A) with uni-dimensionally measurable disease

          -  failure of 1st line chemotherapy including fluoropyrimidine (capecitabine, S1, or
             5-FU,) and platinum (cisplatin or oxaliplatin) in palliative setting; progression
             during or within 6 months after chemotherapy

          -  High expression of pS6 Ser 240/4 (proportion of pS6 Ser 240/4 positive cancer cells by
             immunohistochemistry > 10%)

          -  Age 20 to 75 years old

          -  Estimated life expectancy of more than 3 months

          -  ECOG performance status of 2 or lower

          -  Adequate bone marrow function

          -  Adequate kidney function

          -  Adequate liver function

          -  Fasting serum cholesterol ≤ 300 mg/dL AND fasting triglyceride ≤ 2.5 X ULN

          -  No prior radiation therapy to more than 25% of BM

          -  psychological, familial, sociological or geographical conditions which do not permit
             medical follow-up and compliance with this study

          -  Women of childbearing potential must have a negative pregnancy test on admission

          -  Written informed consent

        Exclusion Criteria:

          -  Other tumor type than adenocarcinoma

          -  CNS metastases or prior radiation for CNS metastases

          -  Gastric outlet obstruction or intestinal obstruction

          -  Evidence of active gastrointestinal bleeding

          -  Bone lesions as the sole evaluable disease

          -  Past or concurrent history of neoplasm other than stomach cancer

          -  Pregnant or lactating women, women of childbearing potential not employing adequate
             contraception

          -  Other serious illness or medical conditions

          -  Concomitant or with a 4-week period administration of any other experimental drug
             under investigation

          -  Concomitant chemotherapy, hormonal therapy, or immunotherapy

          -  Any preexisting medical condition of sufficient severity to prevent full compliance
             with the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment