A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

NCT01099527 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2015-12-29

No results posted yet for this study

Summary

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

  • Metastatic Gastric Cancer

Interventions

DRUG

Everolimus (RAD001)

dose escalation of capecitabine, everolimus

DRUG

Capecitabine

dose escalation of capecitabine, everolimus

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-08-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099527 on ClinicalTrials.gov