A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Efficacy
The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.
June 2012
No
Israel Rios, MD
Study Director
SciClone Pharmaceuticals
United States: Food and Drug Administration
SCI-SCV-MUC-P2b-002
NCT01247246
December 2010
May 2013
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
Beth Israel Medical Center | New York, New York 10003 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Summa Health System | Akron, Ohio 44312 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Temple University Hospital | Philadelphia, Pennsylvania 19140 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Helen F. Graham Cancer Center | Newark, Delaware 19713 |
Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
University of Louisville | Louisville, Kentucky 40202 |
Louisiana State University Health Sciences Center | Shreveport, Louisiana 71130 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Yale University School Of Medicine | New Haven, Connecticut 06520 |
University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
The Nebraska Medical Center | Omaha, Nebraska 68198 |
University of Oklahoma Health Science Center | Oklahoma City, Oklahoma 73104 |
The Christ Hospital Cancer Center | Cincinnati, Ohio 45219 |
St. Agnes Hospital | Baltimore, Maryland 21229 |
Washington University in St. Louis | St. Louis, Missouri 63110 |
Tyler Hematology Oncology | Tyler, Texas 75701 |
Arizona Center for Cancer Care | Glendale, Arizona 85306 |
Lake County Oncology and Hematology | The Villages, Florida 32159 |
Disney Family Cancer Center | Burbank, California 91505 |
VA Long Beach Health System | Long Beach, California 90822 |
Pomona Valley Hospital | Pomona, California 91767 |
The Whittingham Cancer Center, Norwalk Hospital | Norwalk, Connecticut 06856 |
The University of Illinois at Chicago | Chicago, Illinois 60612 |
St. John's Cancer Center | Anderson, Indiana 46016 |
Southcoast Hospital Group | Fairhaven, Massachusetts 02719 |
Gershenson Radiation | Detroit, Michigan 48201 |
Veterans Administration NJ Health Care System | East Orange, New Jersey 07018 |
Rochester University Medical Center | Rochester, New York 14642 |
Memorial Hospital of Rhode Island Cancer Center | Pawtucket, Rhode Island 02860 |
Cookeville Regional Cancer Center | Cookeville, Tennessee 38501 |
Kirkland Cancer Center/Jackson Madison County General Hospital | Jackson, Tennessee 38301 |
Medical College of Wisconson | Milwaukee, Wisconsin 53226 |