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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00927589
First received: June 24, 2009
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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 t rastuzumab on carboplatin pharmacokinetics in patients with HER2-positive metast atic 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 el ectrical cycle. The QTcF interval is the QT interval as calculated using Frideri cia's correction; the QTcB interval is the QT interval as calculated using Bazet t's correction.


Condition Intervention Phase
Solid Cancers
Drug: carboplatin
Drug: docetaxel
Drug: trastuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • QTcF interval [ Time Frame: At each postbaseline timepoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of adverse events and serious adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • PK parameters for carboplatin [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • PK parameters for trastuzumab [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • QTcB interval [ Time Frame: At each postbaseline timepoint ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: carboplatin
Intravenous repeating dose
Drug: docetaxel
Intravenous repeating dose
Drug: trastuzumab
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • History of trastuzumab treatment </= 100 days prior to Cycle 1, Day 1
  • Pretreatment QTcF interval > 450 ms as determined by local assessment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927589

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Beverly Hills, California, United States, 90211
La Jolla, California, United States, 92093
San Diego, California, United States, 92123
Santa Rosa, California, United States, 95403
Whittier, California, United States, 90603
United States, Florida
Miami, Florida, United States, 33136
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Montana
Billings, Montana, United States, 59101
United States, New Mexico
Farmington, New Mexico, United States, 87401
United States, New York
Bronx, New York, United States, 10461
United States, Tennessee
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75230
Galveston, Texas, United States, 77555
Houston, Texas, United States, 77024
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
Temple, Texas, United States, 76508
United States, Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Harald Weber, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00927589     History of Changes
Other Study ID Numbers: H4613g, GO01305
Study First Received: June 24, 2009
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
HER2+ Metastatic Cancer
HER2+ Locally Advanced Inoperable Cancer
HER2+ Solid Malignancy

Additional relevant MeSH terms:
Carboplatin
Docetaxel
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014