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
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | February 2013 |
A Phase 1b, Single-arm, Open-label Clinical Trial to Evaluate Corrected QT Interval and Drug-drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With Metastatic 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 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.
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.
Inclusion Criteria:
- Histologic documentation of a HER2-positive solid malignancy in patients with
metastatic or locally advanced inoperable disease
- Left ventricular ejection fraction (LVEF) >/= 50% by multiple-gated acquisition
(MUGA) scan or two-dimensional echocardiography (ECHO) Day 1
Exclusion Criteria:
- History of trastuzumab treatment
- Pretreatment QTcF interval > 450 ms as determined by local assessment
We found this trial at
19
sites
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