CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 59 enrolled
Drug / intervention
carboplatin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00927589
NCT00927589Phase 1Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Jun 25, 2009·Updated Dec 10, 2015

In Brief

A Phase 1 clinical trial evaluating carboplatin, docetaxel, and 1 other intervention for Solid Cancers. Completed, enrolled 59 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Cancers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2009
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.0 years ago

Interventions

carboplatindrug

Intravenous repeating dose

docetaxeldrug

Intravenous repeating dose

trastuzumabdrug

Intravenous repeating dose