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RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer

NCT00253318 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-27

No results posted yet for this study

Summary

Primary:

* To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I).
* To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase I).

Secondary:

* To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel
* To determine the effect of the combination of RAD001 and docetaxel on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination

Conditions

Interventions

DRUG

Docetaxel

40 mg/m\^2 IV over 1 hour on Day 1.

DRUG

RAD001

30 mg orally on Days 1 and 8.

DRUG

Dexamethasone

8 mg orally twice daily for 3 days, starting 24 hours prior to the administration of Docetaxel.

Sponsors & Collaborators

Principal Investigators

  • Stacy Moulder, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-01
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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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 NCT00253318 on ClinicalTrials.gov