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

Completed · Phase 1

Conditions studied: Solid Cancers

In brief

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.

Key facts

Study ID

NCT00927589

Run by

Genentech, Inc.

People needed

59

Starts

2009-07-01

Expected to finish

2013-02-01

Last updated by the study team

2015-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) </= 42 days prior to Cycle 1, Day 1

You may not qualify if…

• History of trastuzumab treatment </= 100 days prior to Cycle 1, Day 1
• Pretreatment QTcF interval > 450 ms as determined by local assessment

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — La Jolla, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Whittier, California, United States
• Study site — Miami, Florida, United States
• Study site — Wichita, Kansas, United States
• Study site — Billings, Montana, United States
• Study site — Farmington, New Mexico, United States
• Study site — The Bronx, New York, United States
• Study site — Memphis, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Galveston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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