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A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors

Inclusion Criteria


Inclusion criteria:

- Advanced or metastatic malignant disease originating from solid tumors

- Adequate recovery from previous therapy or intervention; at least 21 days since major
surgery or prior radiation therapy

- Measurable or evaluable disease

Exclusion criteria:

- Women of childbearing potential (WOCBP) who are breastfeeding, pregnant, or unwilling
or unable to use acceptable contraception during the study and for at least 12 weeks
after the last on-study dose of cetuximab

- Men unwilling to use acceptable contraception during the study if engaged in sexual
relations with a WOCBP

- Symptomatic brain metastasis

- History of myocardial infarction 6 months or less prior to study entry, of severe
congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias

- Clinically relevant abnormality on screening electrocardiogram (ECG), preventing an
accurate measurement of the QT interval

- Congenital long QT syndrome

- History of risk factors for ventricular tachycardia or Torsades de pointes or history
of fainting, unexplained loss of consciousness, or convulsions

- Prolonged QTc interval on screening ECG (greater than 470 msec) using Fridericia's
correction formula

- Heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ECG
measurements

- Implantable pacemaker or automatic implantable cardioverter defibrillator

- Sustained supine systolic blood pressure higher than 150 mmHg or lower than 90 mmHg
or a diastolic blood pressure lower than 45 mmHg or higher than 95 mmHg at screening

- Known history of arterial thrombotic events within 6 months prior to study initiation

- Known history of significant peripheral artery disease

- Current participation in a clinical trial with another investigational new drug or
device

- Receipt of an investigational new drug or device within 21 days prior to enrollment
in this study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline

Outcome Description:

12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.

Outcome Time Frame:

Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA225-315

NCT ID:

NCT00698841

Start Date:

February 2009

Completion Date:

February 2010

Related Keywords:

  • Advanced Cancer
  • Neoplasms

Name

Location

Ocala Oncology CenterOcala, Florida  34474
Pacific Shores Medical GroupLong Beach, California  90813
Georgetown University Medical CenterWashington, District of Columbia  20007
Compassionate Cancer Care Medical Group, IncFountain Valley, California  92708
Cancer Specialists of OklahomaOklahoma City, Oklahoma  73112
Baptist Cancer InstituteJacksonville, Florida  32207
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Austin Cancer CentersAustin, Texas  78759
Pharma ResourceEast Providence, Rhode Island  02915
Donald W. Hill, MDCasa Grande, Arizona  85222
Compassionate Cancer Care Medical Group IncFountain Valley, California  92708
Desert Hospital Comprehensive Cancer CenterPalm Springs, California  92262
American Institute ResearchWhittier, California  90603
Brinz, Burroff, Gurtler, & RussoMetairie, Louisiana  70006