Pancreatic Neuroendocrine Tumor G2 Clinical Trial
Official title:
A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)
Verified date | September 2023 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 21, 2022 |
Est. primary completion date | May 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment - Refractory disease to treatment with an mTOR inhibitor - Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible - Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent - Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma - Patients must have measurable disease - Documented radiological evidence for disease progression (measurable or nonmeasurable) =< 12 months prior to enrollment - NOTE: If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation; at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) - Prior or concurrent therapy with somatostatin analogue (SSA) is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment - Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously - NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable - Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Patients must be able to swallow intact capsules - Leukocytes >= 3,000/mm^3 (within less than or equal to 14 days prior to registration) - Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within less than or equal to 14 days prior to registration) - Hemoglobin >= 10 g/dL (within less than or equal to 14 days prior to registration) - Platelets >= 100 x 10^9/L (within less than or equal to 14 days prior to registration) - Total serum bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to registration) - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (within less than or equal to 14 days prior to registration) - Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min (within less than or equal to 14 days prior to registration) - NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation - Glycosylated hemoglobin (HbA1c) < 7.0% (within less than or equal to 14 days prior to registration) - Fasting serum glucose =< 130 mg/dL (within less than or equal to 14 days prior to registration) - Fasting triglycerides =< 300 mg/dL (within less than or equal to 14 days prior to registration) - Diabetics are allowed if: - Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L), OR - HbA1c =< 7% - Women must not be pregnant or breast-feeding due to potential harm to the fetus from MLN0128 (TAK-228); all females of childbearing potential must have a blood test or urine study within 7 days of registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) - Women of child-bearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 90 days (for female patients) and 120 day (for male patients) after the last dose of study drug, or agree to completely abstain from heterosexual intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug - Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met: - Brain metastases which have been treated - No evidence of disease progression for >= 3 months before the first dose of study drug - No hemorrhage after treatment - Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228 - No ongoing requirement for dexamethasone or anti-epileptic drugs - Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care Exclusion Criteria: - Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity - Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start - Patient must NOT have had previous treatment with any PI3K or AKT inhibitor - NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start - Patients must NOT have previous or concurrent malignancy within 2 years; exceptions are made for patients who meet any of the following conditions: - Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer OR - Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years - No more than 3 prior systemic treatment regimens for advanced PNET - Patients with a history of the following within =< 6 months of study entry are NOT eligible: - Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures - Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures - Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia) - New York Heart Association (NYHA) class III or IV heart failure - Pulmonary embolism - Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including: - Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed - Pulmonary hypertension - Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air - QT syndrome, or torsades de pointes - Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement - Medically significant (symptomatic) bradycardia - History of arrhythmia requiring an implantable cardiac defibrillator - Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long - Patients with known manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228) are INELIGIBLE - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are INELGIBLE because of the potential for pharmacokinetic interactions with MLN0128 (TAK-228) - NO treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, or CYP2C19 within 1 week preceding the first dose of study drug - NO patients receiving systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug - Patients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug |
Country | Name | City | State |
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United States | Pali Momi Medical Center | 'Aiea | Hawaii |
United States | Queen's Cancer Center - Pearlridge | 'Aiea | Hawaii |
United States | The Cancer Center of Hawaii-Pali Momi | 'Aiea | Hawaii |
United States | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania |
United States | Community Hospital of Anaconda | Anaconda | Montana |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | PCR Oncology | Arroyo Grande | California |
United States | Duluth Clinic Ashland | Ashland | Wisconsin |
United States | Northwest Wisconsin Cancer Center | Ashland | Wisconsin |
United States | Sutter Auburn Faith Hospital | Auburn | California |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | Rush - Copley Medical Center | Aurora | Illinois |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | Saint Alphonsus Medical Center-Baker City | Baker City | Oregon |
United States | Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri |
United States | Flaget Memorial Hospital | Bardstown | Kentucky |
United States | Indu and Raj Soin Medical Center | Beavercreek | Ohio |
United States | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota |
United States | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California |
United States | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Central Care Cancer Center - Bolivar | Bolivar | Missouri |
United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota |
United States | Cox Cancer Center Branson | Branson | Missouri |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Harrison Medical Center | Bremerton | Washington |
United States | United Hospital Center | Bridgeport | West Virginia |
United States | Saint Joseph Mercy Brighton | Brighton | Michigan |
United States | Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Montefiore Medical Center-Einstein Campus | Bronx | New York |
United States | Montefiore Medical Center-Weiler Hospital | Bronx | New York |
United States | Saint Joseph Regional Cancer Center | Bryan | Texas |
United States | Highline Medical Center-Main Campus | Burien | Washington |
United States | Mills-Peninsula Medical Center | Burlingame | California |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho |
United States | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Saint Joseph Mercy Canton | Canton | Michigan |
United States | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
United States | Caro Cancer Center | Caro | Michigan |
United States | Carson Tahoe Regional Medical Center | Carson City | Nevada |
United States | SIH Cancer Institute | Carterville | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Eden Hospital Medical Center | Castro Valley | California |
United States | Dayton Physicians LLC-Miami Valley South | Centerville | Ohio |
United States | Miami Valley Hospital South | Centerville | Ohio |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | Memorial Hospital | Chattanooga | Tennessee |
United States | Saint Joseph Mercy Chelsea | Chelsea | Michigan |
United States | Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan |
United States | Northwestern University | Chicago | Illinois |
United States | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin |
United States | Bethesda North Hospital | Cincinnati | Ohio |
United States | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Anderson | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Westside | Cincinnati | Ohio |
United States | Hematology Oncology Consultants-Clarkston | Clarkston | Michigan |
United States | Newland Medical Associates-Clarkston | Clarkston | Michigan |
United States | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina |
United States | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | Billings Clinic-Cody | Cody | Wyoming |
United States | Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado |
United States | UCHealth Memorial Hospital Central | Colorado Springs | Colorado |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Commonwealth Cancer Center-Corbin | Corbin | Kentucky |
United States | Alegent Health Mercy Hospital | Council Bluffs | Iowa |
United States | Greater Regional Medical Center | Creston | Iowa |
United States | Carle on Vermilion | Danville | Illinois |
United States | Sutter Davis Hospital | Davis | California |
United States | Dayton Physician LLC-Miami Valley Hospital North | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Miami Valley Hospital North | Dayton | Ohio |
United States | Beaumont Hospital - Dearborn | Dearborn | Michigan |
United States | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Essentia Health - Deer River Clinic | Deer River | Minnesota |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Mission Cancer and Blood - Laurel | Des Moines | Iowa |
United States | Ascension Saint John Hospital | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Essentia Health Saint Mary's - Detroit Lakes Clinic | Detroit Lakes | Minnesota |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | Essentia Health Cancer Center | Duluth | Minnesota |
United States | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota |
United States | Miller-Dwan Hospital | Duluth | Minnesota |
United States | Mercy Medical Center | Durango | Colorado |
United States | Southwest Oncology PC | Durango | Colorado |
United States | Great Lakes Cancer Management Specialists-Doctors Park | East China Township | Michigan |
United States | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Carle Physician Group-Effingham | Effingham | Illinois |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Walter Knox Memorial Hospital | Emmett | Idaho |
United States | Saint Elizabeth Hospital | Enumclaw | Washington |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Deaconess Clinic Downtown | Evansville | Indiana |
United States | Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota |
United States | Sanford Broadway Medical Center | Fargo | North Dakota |
United States | Sanford Roger Maris Cancer Center | Fargo | North Dakota |
United States | Sanford South University Medical Center | Fargo | North Dakota |
United States | Weisberg Cancer Treatment Center | Farmington Hills | Michigan |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | Lake Region Healthcare Corporation-Cancer Care | Fergus Falls | Minnesota |
United States | Armes Family Cancer Center | Findlay | Ohio |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Orion Cancer Care | Findlay | Ohio |
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 | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Essentia Health - Fosston | Fosston | Minnesota |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Dayton Physicians LLC-Atrium | Franklin | Ohio |
United States | Palo Alto Medical Foundation-Fremont | Fremont | California |
United States | Unity Hospital | Fridley | Minnesota |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
United States | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois |
United States | Mountain Blue Cancer Care Center | Golden | Colorado |
United States | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina |
United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
United States | CHI Health Saint Francis | Grand Island | Nebraska |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Dayton Physicians LLC-Wayne | Greenville | Ohio |
United States | Wayne Hospital | Greenville | Ohio |
United States | Academic Hematology Oncology Specialists | Grosse Pointe Woods | Michigan |
United States | Great Lakes Cancer Management Specialists-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan |
United States | Michigan Breast Specialists-Grosse Pointe Woods | Grosse Pointe Woods | Michigan |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Cancer and Blood Specialists-Henderson | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada |
United States | GenesisCare USA - Henderson | Henderson | Nevada |
United States | Las Vegas Cancer Center-Henderson | Henderson | Nevada |
United States | OptumCare Cancer Care at Seven Hills | Henderson | Nevada |
United States | Essentia Health Hibbing Clinic | Hibbing | Minnesota |
United States | Pulmonary Medicine Center of Chattanooga-Hixson | Hixson | Tennessee |
United States | Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii |
United States | Hawaii Cancer Care Inc-Liliha | Honolulu | Hawaii |
United States | Island Urology | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Kuakini Medical Center | Honolulu | Hawaii |
United States | Queen's Cancer Cenrer - POB I | Honolulu | Hawaii |
United States | Queen's Cancer Center - Kuakini | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital | Honolulu | Hawaii |
United States | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | CHI Saint Vincent Cancer Center Hot Springs | Hot Springs | Arkansas |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Allegiance Health | Jackson | Michigan |
United States | Onslow Memorial Hospital | Jacksonville | North Carolina |
United States | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina |
United States | Essentia Health - Jamestown Clinic | Jamestown | North Dakota |
United States | Capital Region Southwest Campus | Jefferson City | Missouri |
United States | Freeman Health System | Joplin | Missouri |
United States | Mercy Hospital Joplin | Joplin | Missouri |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | CHI Health Good Samaritan | Kearney | Nebraska |
United States | Heartland Hematology and Oncology | Kearney | Nebraska |
United States | First Dayton Cancer Care | Kettering | Ohio |
United States | Greater Dayton Cancer Center | Kettering | Ohio |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Marshfield Clinic - Ladysmith Center | Ladysmith | Wisconsin |
United States | Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois |
United States | Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Saint Clare Hospital | Lakewood | Washington |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Ann M Wierman MD LTD | Las Vegas | Nevada |
United States | Cancer and Blood Specialists-Shadow | Las Vegas | Nevada |
United States | Cancer and Blood Specialists-Tenaya | Las Vegas | Nevada |
United States | Cancer Therapy and Integrative Medicine | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada |
United States | Desert West Surgery | Las Vegas | Nevada |
United States | GenesisCare USA - Fort Apache | Las Vegas | Nevada |
United States | GenesisCare USA - Las Vegas | Las Vegas | Nevada |
United States | GenesisCare USA - Vegas Tenaya | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada |
United States | Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada |
United States | OptumCare Cancer Care at Charleston | Las Vegas | Nevada |
United States | OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada |
United States | OptumCare Cancer Care at MountainView | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada |
United States | Summerlin Hospital Medical Center | Las Vegas | Nevada |
United States | University Cancer Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Saint Joseph Hospital East | Lexington | Kentucky |
United States | Saint Joseph Radiation Oncology Resource Center | Lexington | Kentucky |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Saint Elizabeth Regional Medical Center | Lincoln | Nebraska |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | Hope Cancer Clinic | Livonia | Michigan |
United States | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan |
United States | Saint Joseph London | London | Kentucky |
United States | Longmont United Hospital | Longmont | Colorado |
United States | Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Jewish Hospital | Louisville | Kentucky |
United States | Saints Mary and Elizabeth Hospital | Louisville | Kentucky |
United States | UofL Health Medical Center Northeast | Louisville | Kentucky |
United States | Great Lakes Cancer Management Specialists-Macomb Medical Campus | Macomb | Michigan |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | Michigan Breast Specialists-Macomb Township | Macomb | Michigan |
United States | Cancer Center of Kansas-Manhattan | Manhattan | Kansas |
United States | Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Saint Mary's Oncology/Hematology Associates of Marlette | Marlette | Michigan |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | WVUH-Berkely Medical Center | Martinsburg | West Virginia |
United States | Sovah Health Martinsville | Martinsville | Virginia |
United States | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Cancer Center of Kansas - McPherson | McPherson | Kansas |
United States | Idaho Urologic Institute-Meridian | Meridian | Idaho |
United States | Dayton Physicians LLC-Signal Point | Middletown | Ohio |
United States | Middlesex Hospital | Middletown | Connecticut |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Health Partners Inc | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Community Medical Hospital | Missoula | Montana |
United States | Memorial Medical Center | Modesto | California |
United States | Monroe Cancer Center | Monroe | Michigan |
United States | Monticello Cancer Center | Monticello | Minnesota |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Palo Alto Medical Foundation-Camino Division | Mountain View | California |
United States | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California |
United States | Saint Alphonsus Medical Center-Nampa | Nampa | Idaho |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | Mount Sinai Hospital | New York | New York |
United States | Chancellor Center for Oncology | Newburgh | Indiana |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Sutter Cancer Research Consortium | Novato | California |
United States | Cancer Care Center of O'Fallon | O'Fallon | Illinois |
United States | Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Alegent Health Immanuel Medical Center | Omaha | Nebraska |
United States | Alegent Health Lakeside Hospital | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Hematology and Oncology Consultants PC | Omaha | Nebraska |
United States | Saint Alphonsus Medical Center-Ontario | Ontario | Oregon |
United States | Memorial GYN Plus | Ooltewah | Tennessee |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada |
United States | Palo Alto Medical Foundation Health Care | Palo Alto | California |
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
United States | Midlands Community Hospital | Papillion | Nebraska |
United States | Essentia Health - Park Rapids | Park Rapids | Minnesota |
United States | Parker Adventist Hospital | Parker | Colorado |
United States | Rocky Mountain Cancer Centers-Parker | Parker | Colorado |
United States | Camden Clark Medical Center | Parkersburg | West Virginia |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Mayo Clinic Hospital in Arizona | Phoenix | Arizona |
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 | Huron Medical Center PC | Port Huron | Michigan |
United States | Lake Huron Medical Center | Port Huron | Michigan |
United States | Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho |
United States | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Rocky Mountain Cancer Centers - Pueblo | Pueblo | Colorado |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | Radiation Oncology Associates | Reno | Nevada |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Saint Mary's Regional Medical Center | Reno | Nevada |
United States | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin |
United States | Reid Health | Richmond | Indiana |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Great Lakes Cancer Management Specialists-Rochester Hills | Rochester Hills | Michigan |
United States | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri |
United States | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
United States | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California |
United States | Sutter Roseville Medical Center | Roseville | California |
United States | Sutter Medical Center Sacramento | Sacramento | California |
United States | Ascension Saint Mary's Hospital | Saginaw | Michigan |
United States | Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri |
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 | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | California Pacific Medical Center-Pacific Campus | San Francisco | California |
United States | Kootenai Cancer Clinic | Sandpoint | Idaho |
United States | Essentia Health Sandstone | Sandstone | Minnesota |
United States | Palo Alto Medical Foundation-Santa Cruz | Santa Cruz | California |
United States | Sutter Pacific Medical Foundation | Santa Rosa | California |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Jewish Hospital Medical Center South | Shepherdsville | Kentucky |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Dayton Physicians LLC-Wilson | Sidney | Ohio |
United States | Siouxland Regional Cancer Center | Sioux City | Iowa |
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 | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Mercy Medical Center | Springfield | Massachusetts |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | Springfield Regional Cancer Center | Springfield | Ohio |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Bhadresh Nayak MD PC-Sterling Heights | Sterling Heights | Michigan |
United States | Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
United States | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California |
United States | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri |
United States | Southwest Illinois Health Services LLP | Swansea | Illinois |
United States | ProMedica Flower Hospital | Sylvania | Ohio |
United States | Franciscan Research Center-Northwest Medical Plaza | Tacoma | Washington |
United States | Northwest Medical Specialties PLLC | Tacoma | Washington |
United States | Ascension Saint Joseph Hospital | Tawas City | Michigan |
United States | Sanford Thief River Falls Medical Center | Thief River Falls | Minnesota |
United States | Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado |
United States | Dayton Physicians LLC-Upper Valley | Troy | Ohio |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Carle Cancer Center | Urbana | Illinois |
United States | The Carle Foundation Hospital | Urbana | Illinois |
United States | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | Essentia Health Virginia Clinic | Virginia | Minnesota |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Advanced Breast Care Center PLLC | 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 | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois |
United States | Mercy Hospital Washington | Washington | Missouri |
United States | Marshfield Clinic-Wausau Center | Wausau | Wisconsin |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Saint Mary's Oncology/Hematology Associates of West Branch | West Branch | Michigan |
United States | Mercy Medical Center-West Lakes | West Des Moines | Iowa |
United States | Marshfield Medical Center - Weston | Weston | Wisconsin |
United States | Ascension Via Christi Hospitals Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas - Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Sanford Cancer Center Worthington | Worthington | Minnesota |
United States | Fairview Lakes Medical Center | Wyoming | Minnesota |
United States | Rush-Copley Healthcare Center | Yorkville | Illinois |
United States | Huron Gastroenterology PC | Ypsilanti | Michigan |
United States | Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate | Response includes complete response (CR) and partial response (PR). CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | Assessed every 3 months for the first 2 years, every 6 months for the 3rd year, then annually up to 5 years | |
Secondary | Progression-free Survival (PFS) | PFS was defined as time from study registration to disease progression (as defined by the RECIST criteria) or to death without progression, whichever occurred first. If date of death was greater than 4 months after the date of last documented to be free of progression or if patients were alive and free of progression at the time of the analysis, patients were censored at the time of last disease assessment. If such a date was not available, patients were censored at the time of registration.
Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression. |
Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years | |
Secondary | Disease Control Rate | Disease control rate was defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD) among all eligible patients who started protocol treatment. CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks. | Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years | |
Secondary | Duration of Response | Duration of response was defined as the time from the onset of response (CR or PR, whichever status was recorded first) to first documentation of disease progression. Patients with responses but without documented disease progression were censored at the time of last disease evaluation.
CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression. |
Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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