Clinical trial · Interventional
A Trial of RAD001/Capecitabine in Refractory Gastric Cancer
A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer
NCT01099527CI-TRIAL-00020362completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory gastric cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Everolimus (RAD001) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Everolimus (RAD001) dose escalation of capecitabine, everolimus Capecitabine dose escalation of capecitabine, everolimus
- interventionNames
- Drug: Everolimus (RAD001)
- Drug: Capecitabine
Primary outcomes (2)
- measure
- To determine maximum tolerated dose (MTD) in phase I
- timeFrame
- 1 year
- measure
- To assess response rate in phase II
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLee SJ, Lee J, Lee J, Park SH, Park JO, Park YS, Lim HY, Kim KM, Do IG, Jung SH, Yim DS, Kang WK. Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients. Invest New Drugs. 2013 Dec;31(6):1580-6. doi: 10.1007/s10637-013-0022-0. Epub 2013 Sep 7. PMID 24013904