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A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer
NCT00927589 · View on ClinicalTrials.gov ↗
Study Summary
This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable cancer. The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG docetaxel
- DRUG trastuzumab
Study Locations (20)
Texas
- — Dallas
- — Galveston
- — Houston
- — Houston
- — San Antonio
- — Temple
California
- — Beverly Hills
- — La Jolla
- — San Diego
- — Santa Rosa
- — Whittier
Tennessee
- — Memphis
- — Nashville
Arizona
- — Scottsdale
Florida
- — Miami
Kansas
- — Wichita
Montana
- — Billings
New Mexico
- — Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00927589
The ClinicalTrials.gov registry entry for NCT00927589 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Cancers appearing as the primary indexed condition, and to 3 interventions — of which carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00927589 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Texas, California, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00927589 about?
NCT00927589 is a clinical study titled "A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer". This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable cancer. The QT interval...
What is the current status of trial NCT00927589?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2009-07. Estimated completion is 2013-02.
What conditions does trial NCT00927589 study?
This clinical trial studies the following conditions: Solid Cancers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00927589?
The interventions under investigation include: carboplatin (DRUG), docetaxel (DRUG), trastuzumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00927589?
This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00927589 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kansas, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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