A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination With Paclitaxel in Patients With Advanced Anaplastic Thyroid Cancer

Who is this study for? Adult patients with Advanced Anaplastic Thyroid Cancer
Status: Completed
Location: See all (253) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ Patients must have histologically or cytologically diagnosed advanced anaplastic thyroid cancer (ATC)

‣ Patients must have measurable disease

‣ Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB)

‣ Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1

‣ There is no limit to the number of prior lines of treatment a patient has received

‣ No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =\< 21 days before study registration

‣ No prior taxane therapy =\< 6 months, except as a radiosensitizer

‣ No history of the following:

⁃ Class III or IV congestive heart failure (CHF)

• Grade 3 or 4 thromboembolic event =\< 6 months

• Pericardial effusion =\< 12 months (any grade)

• Pericardial involvement with tumor

• Grade 2 or higher pleural effusion =\< 6 months

‣ No current symptomatic, untreated, or uncontrolled brain metastases present

‣ No major surgery =\< 14 days prior to registration

‣ No grade 2 or higher neuropathy

‣ No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations

‣ Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required

‣ Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible

‣ Patients with known hypersensitivity to any TZD oral agents are not eligible

‣ Eastern Cooperative Oncology Group (ECOG) performance status =\< 2

‣ Absolute neutrophil count (ANC) \>= 1,500/mm\^3

‣ Platelet count \>= 100,000/mm\^3

‣ Creatinine =\< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine clearance \>= 60 mL/min

‣ Bilirubin =\< 1.5 x ULN

‣ Aspartate aminotransferase (AST) =\< 2.5 x ULN

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Regional Hospital
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Arizona
Mayo Clinic Hospital
Phoenix
Mayo Clinic in Arizona
Scottsdale
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Colorado
University of Colorado Hospital
Aurora
Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Smilow Cancer Center/Yale-New Haven Hospital
New Haven
Yale University
New Haven
Delaware
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Christiana Gynecologic Oncology LLC
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Regional Hematology and Oncology PA
Newark
Beebe Health Campus
Rehoboth Beach
Nanticoke Memorial Hospital
Seaford
Christiana Care Health System-Wilmington Hospital
Wilmington
Florida
Mayo Clinic in Florida
Jacksonville
Hawaii
Hawaii Oncology Inc-Pali Momi
'aiea
Pali Momi Medical Center
'aiea
The Cancer Center of Hawaii-Pali Momi
'aiea
Hawaii Cancer Care Inc-Liliha
Honolulu
Hawaii Cancer Care Inc-POB II
Honolulu
Hawaii Oncology Inc-Kuakini
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Kuakini Medical Center
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Mountain States Tumor Institute
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Kootenai Medical Center
Coeur D'alene
Walter Knox Memorial Hospital
Emmett
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland
Idaho Urologic Institute-Meridian
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian
Saint Alphonsus Medical Center-Nampa
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa
Kootenai Cancer Center
Post Falls
Kootenai Cancer Clinic
Sandpoint
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls
Illinois
Northwestern University
Chicago
Kansas
Cancer Center of Kansas - Chanute
Chanute
Cancer Center of Kansas - Dodge City
Dodge City
Cancer Center of Kansas - El Dorado
El Dorado
Cancer Center of Kansas - Fort Scott
Fort Scott
Central Care Cancer Center - Garden City
Garden City
Central Care Cancer Center - Great Bend
Great Bend
Cancer Center of Kansas-Independence
Independence
Cancer Center of Kansas-Kingman
Kingman
Lawrence Memorial Hospital
Lawrence
Kansas Institute of Medicine Cancer and Blood Center
Lenexa
Minimally Invasive Surgery Hospital
Lenexa
Cancer Center of Kansas-Liberal
Liberal
Cancer Center of Kansas-Manhattan
Manhattan
Cancer Center of Kansas - McPherson
Mcpherson
Cancer Center of Kansas - Newton
Newton
Menorah Medical Center
Overland Park
Saint Luke's South Hospital
Overland Park
Cancer Center of Kansas - Parsons
Parsons
Cancer Center of Kansas - Pratt
Pratt
Cancer Center of Kansas - Salina
Salina
Cancer Center of Kansas - Wellington
Wellington
Associates In Womens Health
Wichita
Cancer Center of Kansas - Wichita
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Via Christi Regional Medical Center
Wichita
Cancer Center of Kansas - Winfield
Winfield
Massachusetts
Mercy Medical Center
Springfield
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
IHA Hematology Oncology Consultants-Brighton
Brighton
Saint Joseph Mercy Brighton
Brighton
IHA Hematology Oncology Consultants-Canton
Canton
Saint Joseph Mercy Canton
Canton
Caro Cancer Center
Caro
IHA Hematology Oncology Consultants-Chelsea
Chelsea
Saint Joseph Mercy Chelsea
Chelsea
Hematology Oncology Consultants-Clarkston
Clarkston
Newland Medical Associates-Clarkston
Clarkston
Beaumont Hospital-Dearborn
Dearborn
Ascension Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Great Lakes Cancer Management Specialists-Doctors Park
East China Township
Genesee Cancer and Blood Disease Treatment Center
Flint
Genesee Hematology Oncology PC
Flint
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods
Lymphoma Clinic of Michigan
Grosse Pointe Woods
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods
Allegiance Health
Jackson
Sparrow Hospital
Lansing
Hope Cancer Clinic
Livonia
Saint Mary Mercy Hospital
Livonia
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb
Michigan Breast Specialists-Macomb Township
Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette
21st Century Oncology-Pontiac
Pontiac
Hope Cancer Center
Pontiac
Newland Medical Associates-Pontiac
Pontiac
Saint Joseph Mercy Oakland
Pontiac
Lake Huron Medical Center
Port Huron
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills
Oncology Hematology Associates of Saginaw Valley PC
Saginaw
Saint Mary's of Michigan
Saginaw
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights
Saint Joseph Health System-Tawas City
Tawas City
Advanced Breast Care Center PLLC
Warren
Bhadresh Nayak MD PC-Warren
Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren
Macomb Hematology Oncology PC
Warren
Michigan Breast Specialists-Warren
Warren
Saint John Macomb-Oakland Hospital
Warren
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch
Huron Gastroenterology PC
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Fairview-Southdale Hospital
Edina
Unity Hospital
Fridley
Fairview Maple Grove Medical Center
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
New Ulm Medical Center
New Ulm
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic
Rochester
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Fairview Lakes Medical Center
Wyoming
Missouri
Central Care Cancer Center - Bolivar
Bolivar
Centerpoint Medical Center LLC
Independence
Freeman Health System
Joplin
Heartland Hematology and Oncology Associates Incorporated
Kansas City
Research Medical Center
Kansas City
Saint Luke's Hospital of Kansas City
Kansas City
Saint Luke's East - Lee's Summit
Lee's Summit
Liberty Radiation Oncology Center
Liberty
Delbert Day Cancer Institute at PCRMC
Rolla
Heartland Regional Medical Center
Saint Joseph
Mercy Hospital Saint Louis
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Washington University School of Medicine
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Bozeman Deaconess Hospital
Bozeman
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Saint Peter's Community Hospital
Helena
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Dakota
Sanford Bismarck Medical Center
Bismarck
Roger Maris Cancer Center
Fargo
Sanford Broadway Medical Center
Fargo
Ohio
University of Cincinnati/Barrett Cancer Center
Cincinnati
Ohio State University Comprehensive Cancer Center
Columbus
University Pointe
West Chester
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Alphonsus Medical Center-Baker City
Baker City
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Oncology and Hematology Care Southeast
Clackamas
Bay Area Hospital
Coos Bay
Providence Newberg Medical Center
Newberg
Saint Alphonsus Medical Center-Ontario
Ontario
Providence Willamette Falls Medical Center
Oregon City
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Saint Charles Health System-Redmond
Redmond
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Geisinger Medical Center
Danville
Pocono Medical Center
East Stroudsburg
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Lehigh Valley Hospital-Hazleton
Hazleton
Geisinger Medical Oncology-Lewisburg
Lewisburg
Lewistown Hospital
Lewistown
Geisinger Cancer Services-Pottsville
Pottsville
Community Medical Center
Scranton
Geisinger Medical Oncology-Selinsgrove
Selinsgrove
Geisinger Medical Group
State College
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
South Carolina
Greenville Health System Cancer Institute-Easley
Easley
Greenville Health System Cancer Institute-Andrews
Greenville
Greenville Health System Cancer Institute-Butternut
Greenville
Greenville Health System Cancer Institute-Eastside
Greenville
Greenville Health System Cancer Institute-Faris
Greenville
Greenville Memorial Hospital
Greenville
Greenville Health System Cancer Institute-Greer
Greer
Greenville Health System Cancer Institute-Seneca
Seneca
Greenville Health System Cancer Institute-Spartanburg
Spartanburg
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
Cancer Care Center at Island Hospital
Anacortes
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton
Providence Regional Cancer System-Centralia
Centralia
Swedish Medical Center-Edmonds
Edmonds
Providence Regional Cancer Partnership
Everett
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Providence Regional Cancer System-Lacey
Lacey
PeaceHealth Saint John Medical Center
Longview
Jefferson Healthcare
Port Townsend
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
Kaiser Permanente Washington
Seattle
Minor and James Medical PLLC
Seattle
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Providence Regional Cancer System-Shelton
Shelton
Evergreen Hematology and Oncology PS
Spokane
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane
Rockwood North Cancer Treatment Center
Spokane
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
Froedtert and the Medical College of Wisconsin
Milwaukee
Cancer Center of Western Wisconsin
New Richmond
Wyoming
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Time Frame
Start Date: 2014-12-30
Completion Date: 2023-04-15
Participants
Target number of participants: 19
Treatments
Experimental: efatutazone dihydrochloride, paclitaxel
Patients receive paclitaxel IV over 3 hours on day 1 and efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: Daiichi Sankyo, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov