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NCT00927589 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Solid Cancers, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT00927589: Completed Phase 1 study of Solid Cancers, sponsored by Genentech.
NCT00927589 is a Phase 1 study of Solid Cancers that has completed, run by Genentech. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00927589, a Phase 1 study of Solid Cancers, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 (C1D8) and Cycl
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 |
What the finished NCT00927589 record still lists
NCT00927589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
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.
NCT00927589 names 20 study sites across 10 states, led by Texas, California, Tennessee.
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.
What interventions are being tested in trial NCT00927589?
The interventions under investigation include: carboplatin (DRUG), docetaxel (DRUG), trastuzumab (DRUG).
Who is sponsoring clinical trial NCT00927589?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00927589's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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