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Phase I Oral mTOR Inhibitor RAD001 in Combo w/ Capecitabine for Metastatic Breast

NCT00473005 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-05-28

No results posted yet for this study

Summary

In order to improve the survival of metastatic breast patients, it is important to investigate the use of novel therapeutic agents combined with known active agents in the treatment of breast cancer. This is a phase I study evaluating the maximum tolerated doses and toxicities of RAD001 in combination with capecitabine for the treatment of metastatic breast cancer. RAD001 (INN: everolimus) is a novel macrolide, which is being developed as an antiproliferative drug with applications as an immunosuppressant and anticancer agent. Phase I trials in patients with solid tumors have shown that treatment with RAD001 is well-tolerated with a minimal side effect profile. Capecitabine (Xeloda, Roche) is an oral fluoropyrimidine that was approved in 1998 for the treatment of patients with metastatic breast cancer. The all-oral regimen of RAD001 with capecitabine is an attractive approach as the treatment of metastatic breast cancer has not yet proven to be curative. We also want to find out what possible benefit this combination of drugs might have on treating your cancer.

Conditions

Interventions

DRUG

Capecitabine

825 mg/m2 bid, Oral

DRUG

RAD001

2.5mg QOD, 2.5mg QD, 5.0mg QD, Oral

Sponsors & Collaborators

Principal Investigators

  • Dr. Ellie Guardino MD/PhD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00473005 on ClinicalTrials.gov