Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma
PRIMARY OBJECTIVES:
I. To assess the six-month progression-free survival and one-year overall survival
probability in Stage IV melanoma patients treated with RO4929097 (gamma-secretase/Notch
signalling pathway inhibitor RO4929097).
SECONDARY OBJECTIVES:
I. To investigate in a preliminary manner the relationship between Notch activation status
and gene expression profile of tumor and clinical outcomes from patients in this study.
II. To study the effects of the investigational therapy on T cell function, which will
provide a basis for subsequent trials combining Notch blockade with immunomodulatory therapy
for advanced melanoma.
III. To assess the response rate (confirmed and unconfirmed complete and partial responses).
IV. To assess toxicity.
OUTLINE: This is a multicenter study.
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) on
days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
Some patients undergo blood collection at baseline and during study for analysis of T-cell
function by flow cytometry and ELISA. Tumor tissue samples from biopsy or surgery are also
analyzed for Notch activation by IHC and qRT-PCR.
After completion of study therapy, patients are followed up every 3 months for 1 year and
then every 6 months for 2 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 months
No
Kim Margolin
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2011-02040
NCT01120275
October 2010
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Wesley Medical Center | Wichita, Kansas 67214 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Munson Medical Center | Traverse City, Michigan 49684 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Good Samaritan Hospital - Cincinnati | Cincinnati, Ohio 45220 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Salina Regional Health Center | Salina, Kansas 67401 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Grandview Hospital | Dayton, Ohio 45405 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Adventist Medical Center | Portland, Oregon 97216 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Memorial Medical Center | Springfield, Illinois 62781 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Wellmont Holston Valley Hospital and Medical Center | Kingsport, Tennessee 37662 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Providence Hospital | Mobile, Alabama 36608 |
Tahoe Forest Cancer Center | Truckee, California 96161 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Maui Memorial Medical Center | Wailuku, Hawaii 96793 |
University of Rochester | Rochester, New York 14642 |
Wayne State University | Detroit, Michigan 48202 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Columbus CCOP | Columbus, Ohio 43206 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Virginia Mason CCOP | Seattle, Washington 98101 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Hawaii Medical Center East | Honolulu, Hawaii 96817 |
Castle Medical Center | Kailua, Hawaii 96734 |
Hays Medical Center | Hays, Kansas 67601 |
Saint Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
Fremont - Rideout Cancer Center | Marysville, California 95901 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Anthony's Health | Alton, Illinois 62002 |
Good Samaritan Regional Medical Center | Mt. Vernon, Illinois 62864 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Genesis Medical Center - East Campus | Davenport, Iowa 52803 |
Saint Francis Hospital and Medical Center - Topeka | Topeka, Kansas 66606 |
Louisiana State University Sciences Center- Monroe | Monroe, Louisiana 71210 |
Highland Clinic | Shreveport, Louisiana 71105 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Saint Louis-Cape Girardeau CCOP | Saint Louis, Missouri 63141 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Mission Hospitals Inc | Asheville, North Carolina 28801 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
AnMed Health Hospital | Anderson, South Carolina 29621 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Evergreen Hospital Medical Center | Kirkland, Washington 98033 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Denver Veterans Administration Medical Center | Denver, Colorado 80220 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Central Care Cancer Center-Carrie J Babb Cancer Center | Bolivar, Missouri 65613 |
Skaggs Cancer Center | Branson, Missouri 65616 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Kansas City CCOP | Prairie Village, Kansas 66208 |
Memorial Hospital Of Martinsville | Martinsville, Virginia 24115 |
Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center-Main Campus | Burien, Washington 98166 |
Pacific Medical Center-First Hill | Seattle, Washington 98104 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Via Christi Hospital-Pittsburg | Pittsburg, Kansas 66762 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Promise Regional Medical Center-Hutchinson | Hutchinson, Kansas 65702 |
Saint Louis Cancer and Breast Institute-South City | Saint Louis, Missouri 63109 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |