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 - Full Text View

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 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.

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 Traztuzumab on Carboplatin in the Presence of Docetaxel in Patients With Metastatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Drug Reactions

Drug Information available for: Carboplatin Docetaxel Trastuzumab

U.S. FDA Resources

Further study details as provided by Genentech:

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 ]

Estimated Enrollment:	55
Study Start Date:	July 2009
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	May 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

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

Contacts

Contact: Please reference Study ID Number: H4613g www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, Arizona
	Active, not recruiting
Scottsdale, Arizona, United States, 85258
United States, California
	Active, not recruiting
Beverly Hills, California, United States, 90211
	Completed
La Jolla, California, United States, 92093
	Active, not recruiting
San Diego, California, United States, 92123
	Completed
Santa Rosa, California, United States, 95403
	Active, not recruiting
Whittier, California, United States, 90603
United States, Florida
	Completed
Miami, Florida, United States, 33136
United States, Kansas
	Active, not recruiting
Wichita, Kansas, United States, 67214
United States, Montana
	Active, not recruiting
Billings, Montana, United States, 59101
United States, New York
	Recruiting
Bronx, New York, United States, 10461
United States, Tennessee
	Active, not recruiting
Memphis, Tennessee, United States, 38119
	Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
	Active, not recruiting
Dallas, Texas, United States, 75230
	Active, not recruiting
Galveston, Texas, United States, 77555
	Completed
Houston, Texas, United States, 77024
	Active, not recruiting
San Antonio, Texas, United States, 78229
	Active, not recruiting
Temple, Texas, United States, 76508
United States, Washington
	Completed
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Harald Weber, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00927589 History of Changes
Other Study ID Numbers:	H4613g, GO01305
Study First Received:	June 24, 2009
Last Updated:	January 4, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

HER2+ Metastatic Cancer
HER2+ Locally Advanced Inoperable Cancer
HER2+ Solid Malignancy

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Docetaxel

Trastuzumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013