Spots Global Cancer Trial Database for Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
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Trial Identification
Brief Title: Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
Official Title: A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination With Paclitaxel in Patients With Advanced Anaplastic Thyroid Cancer
Study ID: NCT02152137
Study Description
Brief Summary: This phase II trial studies how well inolitazone dihydrochloride (efatutazone dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description: PRIMARY OBJECTIVES: I. To determine if the combination of paclitaxel and efatutazone (efatutazone dihydrochloride) improves the confirmed response rate in patients with advanced anaplastic thyroid cancer. SECONDARY OBJECTIVES: I. To estimate the overall survival (OS), duration of response, progression-free survival (PFS), and adverse event rates for the combination of paclitaxel and efatutazone. TERTIARY OBJECTIVES: I. The association of biomarkers with clinical outcome data will be assessed in an exploratory translational analysis. OUTLINE: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1 and efatutazone dihydrochloride orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 28 days, every 8 weeks until disease progression, and then every 6 months for 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alaska Regional Hospital, Anchorage, Alaska, United States
Alaska Women's Cancer Care, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Mayo Clinic Hospital, Phoenix, Arizona, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC, Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Regional Hematology and Oncology PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital, Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Hawaii Oncology Inc-Pali Momi, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc-POB II, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini, Honolulu, Hawaii, United States
Kuakini Medical Center, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute, Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States
Kootenai Medical Center, Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital, Emmett, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland, Idaho, United States
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian, Meridian, Idaho, United States
Saint Alphonsus Medical Center-Nampa, Nampa, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa, Nampa, Idaho, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, United States
Northwestern University, Chicago, Illinois, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Central Care Cancer Center - Garden City, Garden City, Kansas, United States
Central Care Cancer Center - Great Bend, Great Bend, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Kansas Institute of Medicine Cancer and Blood Center, Lenexa, Kansas, United States
Minimally Invasive Surgery Hospital, Lenexa, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Saint Luke's South Hospital, Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Mercy Medical Center, Springfield, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
IHA Hematology Oncology Consultants-Brighton, Brighton, Michigan, United States
Saint Joseph Mercy Brighton, Brighton, Michigan, United States
IHA Hematology Oncology Consultants-Canton, Canton, Michigan, United States
Saint Joseph Mercy Canton, Canton, Michigan, United States
Caro Cancer Center, Caro, Michigan, United States
IHA Hematology Oncology Consultants-Chelsea, Chelsea, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston, Clarkston, Michigan, United States
Newland Medical Associates-Clarkston, Clarkston, Michigan, United States
Beaumont Hospital-Dearborn, Dearborn, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States
Genesee Hematology Oncology PC, Flint, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States
Lymphoma Clinic of Michigan, Grosse Pointe Woods, Michigan, United States
Michigan Breast Specialists-Grosse Pointe Woods, Grosse Pointe Woods, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Hope Cancer Clinic, Livonia, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States
Michigan Breast Specialists-Macomb Township, Macomb, Michigan, United States
Saint Mary's Oncology/Hematology Associates of Marlette, Marlette, Michigan, United States
21st Century Oncology-Pontiac, Pontiac, Michigan, United States
Hope Cancer Center, Pontiac, Michigan, United States
Newland Medical Associates-Pontiac, Pontiac, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, United States
Great Lakes Cancer Management Specialists-Rochester Hills, Rochester Hills, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, United States
Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, United States
Saint Joseph Health System-Tawas City, Tawas City, Michigan, United States
Advanced Breast Care Center PLLC, Warren, Michigan, United States
Bhadresh Nayak MD PC-Warren, Warren, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, United States
Macomb Hematology Oncology PC, Warren, Michigan, United States
Michigan Breast Specialists-Warren, Warren, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch, West Branch, Michigan, United States
Huron Gastroenterology PC, Ypsilanti, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor, Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Fairview Maple Grove Medical Center, Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Health Partners Inc, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Fairview Lakes Medical Center, Wyoming, Minnesota, United States
Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
Freeman Health System, Joplin, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center, Liberty, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Roger Maris Cancer Center, Fargo, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
University of Cincinnati/Barrett Cancer Center, Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University Pointe, West Chester, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Saint Alphonsus Medical Center-Baker City, Baker City, Oregon, United States
Saint Charles Health System, Bend, Oregon, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Oncology and Hematology Care Southeast, Clackamas, Oregon, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States
Providence Willamette Falls Medical Center, Oregon City, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Saint Charles Health System-Redmond, Redmond, Oregon, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Pocono Medical Center, East Stroudsburg, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton, Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Community Medical Center, Scranton, Pennsylvania, United States
Geisinger Medical Oncology-Selinsgrove, Selinsgrove, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Greenville Health System Cancer Institute-Easley, Easley, South Carolina, United States
Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Greenville Memorial Hospital, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer, Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States
Cancer Care Center at Island Hospital, Anacortes, Washington, United States
Swedish Cancer Institute-Eastside Oncology Hematology, Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States
Providence Regional Cancer System-Centralia, Centralia, Washington, United States
Swedish Medical Center-Edmonds, Edmonds, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Providence Regional Cancer System-Lacey, Lacey, Washington, United States
PeaceHealth Saint John Medical Center, Longview, Washington, United States
Jefferson Healthcare, Port Townsend, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States
Minor and James Medical PLLC, Seattle, Washington, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Swedish Medical Center-Ballard Campus, Seattle, Washington, United States
Kaiser Permanente Washington, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
Swedish Medical Center-Cherry Hill, Seattle, Washington, United States
PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton, Shelton, Washington, United States
Rockwood Clinic Cancer Treatment Center-Valley, Spokane Valley, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown, Spokane, Washington, United States
Evergreen Hematology and Oncology PS, Spokane, Washington, United States
Rockwood North Cancer Treatment Center, Spokane, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Providence Regional Cancer System-Yelm, Yelm, Washington, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: Robert Smallridge, M.D.
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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