Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

NCT00465673 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2009-08-06

No results posted yet for this study

Summary

Primary objective:

To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis

Secondary objectives:

1. To determine the overall objective response rate (ORR)
2. To determine the progression free survival, and duration of objective response
3. To evaluate the overall survival (OS)
4. To assess the safety profiles

Conditions

Interventions

DRUG

Liposomal Doxorubicin

40mg/m2 over 1 hour infusion for 21 days

Sponsors & Collaborators

  • TTY Biopharm

    collaborator INDUSTRY
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Alex Chang · Johns Hopkins SIngapore International Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Singapore

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 NCT00465673 on ClinicalTrials.gov