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Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer

Phase 2
Completed
Conditions
Breast Neoplasms
Interventions
Drug: Chemotherapy
Registration Number
NCT00048633
Lead Sponsor
QLT Inc.
Brief Summary

The primary objective of this phase II study is to assess if XR9576, a selective MDR-1 inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast cancer. Clinical activity will be measured by objective tumor response rates observed after treatment with XR9576 in combination with taxane or anthracycline containing chemotherapy in patients previously resistant to the same agent(s).

The secondary objectives of the study are to assess the biological activity of XR9576 and evaluate MDR-1 expression in these tumors. The MDR-1 inhibitory activity of XR9576 will be evaluated by serial sestamibi scans of the tumor. MDR-1 expression will be detected by immunohistochemistry.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TariquidarChemotherapy-
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

Florida Oncology Associates

🇺🇸

Jacksonville, Florida, United States

Arlington Cancer Center

🇺🇸

Arlington, Texas, United States

Medical Center of Vincennes

🇺🇸

Vincennes, Indiana, United States

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