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NCT00048633 · ClinicalTrials.gov registry record · Phase 2
Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer
A Phase 2 study of Breast Neoplasms, sponsored by QLT.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT00048633 is a Phase 2 study of Breast Neoplasms that has completed, run by QLT. The registered enrollment target is 30 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT00048633, a Phase 2 study of Breast Neoplasms, has completed, sponsored by QLT.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Chemotherapy
Study Locations (4)
Texas
- Arlington Cancer Center - Arlington
- MD Anderson Cancer Center - Houston
Florida
- Florida Oncology Associates - Jacksonville
Indiana
- Medical Center of Vincennes - Vincennes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-11 |
| Est. Completion | 2003-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048633
The ClinicalTrials.gov registry entry for NCT00048633 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (95% lower). The listed sponsor is QLT, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Chemotherapy is the first listed.
NCT00048633 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Texas, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00048633 about?
NCT00048633 is a clinical study titled "Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer". 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 combin...
What is the current status of trial NCT00048633?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2001-11. Estimated completion is 2003-06.
What conditions does trial NCT00048633 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT00048633?
The interventions under investigation include: Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT00048633?
This trial is sponsored by QLT, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00048633 being conducted?
This trial has 4 study locations across Florida, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.