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A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Gastric Cancer

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Trial Information

A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Inclusion Criteria:

1. Histologically or cytologically proven gastric cancer patients

2. Adequate organ function as defined by the following criteria:

A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT))
and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤
2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal
to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total
serum bilirubin ≤ 3.0 mg/dL C. Absolute neutrophil count (ANC) ≥1500/µL D. Platelets
≥100,000/µL E. Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F.
Serum calcium ≤12.0 mg/dL G. Serum creatinine ≤1.5 x ULN

3. Patients with CNS metastasis must have stable neurologic function without evidence of
CNS progression within 8 weeks

4. Patients who have failed to at least two previous cytotoxic chemotherapy for advanced
gastric cancer (adjuvant treatment will be counted as one regimen if received < 12
months from the start of experimental treatment)

5. At least one measurable lesion by RECIST criteria

6. ECOG PS 0-2

7. Patients with informed consent

Exclusion Criteria:

1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.

2. History of or known carcinomatous meningitis, or evidence of symptomatic
leptomeningeal disease on screening CT or MRI scan.

3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.

4. Pregnancy or breastfeeding.

5. Prior exposure to the study drug.

6. Patients unable to swallow oral medications.

Type of Study:


Study Design:

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

Outcome Measure:

To determine maximum tolerated dose (MTD) in phase I

Outcome Time Frame:

1 year

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

April 2012

Related Keywords:

  • Metastatic Gastric Cancer
  • gastric cancer
  • refractory
  • metastatic
  • Stomach Neoplasms