Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. To assess the response rate (confirmed complete and partial response) of patients with
locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197
(tivantinib) or ARQ 197 combined with erlotinib (erlotinib hydrochloride).
SECONDARY OBJECTIVES:
I. To assess the progression free survival (PFS) of patients with locally advanced or
metastatic papillary renal cell carcinoma treated with either ARQ 197 or ARQ 197 combined
with erlotinib.
II. To assess the safety and tolerability of ARQ 197 therapy and ARQ 197 combined with
erlotinib.
III. To bank tissue specimens for future use and once funding is obtained to evaluate the
expression of tissue correlative biomarkers such as hepatocyte growth factor receptor
(c-MET) and epidermal growth factor receptor (EGFR), and to perform exploratory correlation
with clinical outcomes.
IV. To descriptively assess the role of prior treatment on outcome.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28.
ARM II: Patients receive tivantinib PO BID and erlotinib hydrochloride PO once daily (QD) on
days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months for up to 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (confirmed complete response [CR] or partial response [PR]), determined according to Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 3 years
No
Przemyslaw Twardowski
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2012-01641
NCT01688973
August 2012
Name | Location |
---|---|
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Group Health Cooperative | Seattle, Washington 98112 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
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 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Grandview Hospital | Dayton, Ohio 45405 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
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 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Providence Medical Center | Kansas City, Kansas 66112 |
Hennepin County Medical Center | Minneapolis, Minnesota |
University of Rochester | Rochester, New York 14642 |
Glens Falls Hospital | Glens Falls, New York 12801 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Wayne State University | Detroit, Michigan 48202 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
Columbus CCOP | Columbus, Ohio 43206 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
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 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
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 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
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 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Saint Louis-Cape Girardeau CCOP | Saint Louis, Missouri 63141 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Veterans Adminstration New Jersey Health Care System | East Orange, New Jersey 07018-1095 |
Orange Regional Medical Center | Middletown, New York 10940 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
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 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Kansas City CCOP | Prairie Village, Kansas 66208 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Joseph Oncology Inc | Saint Joseph, Missouri 64507 |
The Mark H Zangmeister Center | Columbus, Ohio 43219 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center-Main Campus | Burien, Washington 98166 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Swedish Cancer Institute-Issaquah | Issaquah, Washington 98029 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Saint Louis Cancer and Breast Institute-South City | Saint Louis, Missouri 63109 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
Idaho Urologic Institute PA | Meridian, Idaho 83642 |
Hines Veterans Administration Hospital | Hines, Illinois 60141 |