Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
NCT ID: NCT00698841
Last Updated: 2015-12-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2009-02-28
2010-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cetuximab
Cetuximab
Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m\^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m\^2 over 60 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cetuximab
Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m\^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m\^2 over 60 minutes.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adequate recovery from previous therapy or intervention; at least 21 days since major surgery or prior radiation therapy
* Measurable or evaluable disease
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Donald W. Hill, MD
Casa Grande, Arizona, United States
Compassionate Cancer Care Medical Group, Inc
Corona, California, United States
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Desert Hospital Comprehensive Cancer Center
Palm Springs, California, United States
Compassionate Cancer Care Medical Group, Inc
Riverside, California, United States
American Institute Research
Whittier, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Brinz, Burroff, Gurtler, & Russo
Metairie, Louisiana, United States
Cancer Specialists Of Oklahoma
Oklahoma City, Oklahoma, United States
Pharma Resource
East Providence, Rhode Island, United States
Austin Cancer Centers
Austin, Texas, United States
Local Institution
San Juan, Pr, Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Deeken JF, Shimkus B, Liem A, Hill D, Gurtler J, Berghorn E, Townes L, Lu H, Trifan O, Zhang S. Evaluation of the relationship between cetuximab therapy and corrected QT interval changes in patients with advanced malignancies from solid tumors. Cancer Chemother Pharmacol. 2013 Jun;71(6):1473-83. doi: 10.1007/s00280-013-2146-5. Epub 2013 Apr 16.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA225-315
Identifier Type: -
Identifier Source: org_study_id