Know Cancer

forgot password

A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer

Phase 1
18 Years
70 Years
Open (Enrolling)
Advanced Gastric Cancer

Thank you

Trial Information

A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer

For the first cohort of this phase I study, each drug of capecitabine, oxaliplatin, and
RAD001 will be started at one or two dose below the ordinary full dose of each drug as a
single agent.

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

- 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

- Other serious illness or medical conditions

- Patients with known history of ischemic heart disease and/or with myocardial

- Known allergy to study drugs

- Administration of drugs showing interaction with RAD001

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the maximum tolerated dose (MTD)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

February 2010

Completion Date:

November 2012

Related Keywords:

  • Advanced Gastric Cancer
  • RAD001
  • phase 1
  • Stomach Neoplasms