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A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Stomach Neoplasm

Thank you

Trial Information

A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer

Inclusion Criteria:

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

- Patients must have non-resectable disease by metastasis or recurrent disease after
curative surgical resection with uni-dimensionally measurable disease (at least
longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or
physical examination)

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

- Age 18 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

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

- Patients must not have 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

- The patient must be able to understand the study and has given written informed
consent to participate in the study

Exclusion Criteria:

- Other tumor types than adenocarcinoma

- Central nervous system metastases or prior radiation for CNS metastasis

- Gastric outlet obstruction or intestinal obstruction

- Evidence of active gastrointestinal bleeding

- Bony metastasis 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

- Thyroid disease

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival rate at 4-month (16 weeks)

Outcome Time Frame:

4 months (16 weeks)

Safety Issue:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

July 2008

Completion Date:

April 2012

Related Keywords:

  • Stomach Neoplasm
  • RAD001 (everolimus)
  • second-line treatment
  • advanced gastric cancer
  • Neoplasms
  • Stomach Neoplasms