TAPUR:测试食品药品管理局(FDA)批准的针对晚期癌症患者肿瘤基因特定异常的药物的使用情况

计划状态

招聘

阶段

第二阶段

允许先接受免疫治疗

CRC 指导的试验

没有

药物

Abemaciclib, afatinib, Atezolizumab and PHESGO, Atezolizumab and Talazoparib, Crizotinib, Entrectinib, Larotrectinib, Nivolumab and Ipilimumab, Olaparib, palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab and Pertuzumab, Tucatinib plus Trastuzumab Subcutaneous (SC), Vemurafenib and Cobimetinib, Cotellic, Herceptin, Perjeta, Zelboraf

标签

MSI-H/ MMRd、MSS/ MMRp

评论

Includes but is not limited to:
HER2 (ERBB2) CRC arm: Participants receive trastuzumab (Herceptin) and pertuzumab (Perjeta)- dosage, frequency and duration per label (ERBB2 (HER2) amplifications)

BRAF CRC arm: Participants receive vemurafenib (BRAF inhibitor, Zelboraf) and cobimetinib (MEK inhibitor, Cotellic) – dosage, frequency and duration per label BRAFV600E mutations

POLE, POLD1 mutations arm: Participants receive pembrolizumab – dosage, frequency and duration per label

Measurable disease is one of the key inclusion criteria.

有用链接

地点 位置状态
美国
University of Alabama at Birmingham Comprehensive Cancer Center
阿拉巴马州伯明翰 35294
招聘
Cancer Treatment Centers of America-Phoenix
Phoenix, Arizona 85338
招聘
Sutter Auburn
Auburn, California 95602
招聘
Sutter Alta Bates
Berkeley, California 94705
招聘
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
加利福尼亚州洛杉矶 90025
招聘
Kaiser Permanente - Oakland Medical Center
加利福尼亚州奥克兰市 94611
招聘
Sutter Palo Alto Medical Foundation: Palo Alto
Palo Alto, California 94301
招聘
Kaiser Permanente - Roseville Medical Center
加利福尼亚州罗斯维尔 95661
招聘
Sutter Roseville
加利福尼亚州罗斯维尔 95661
招聘
Kaiser Permanente - Sacramento Medical Center
加利福尼亚州萨克拉门托 95814
招聘
Sutter Sacramento
Sacramento, California 95816
招聘
Kaiser Permanente - South San Francisco Medical Center
加利福尼亚州旧金山 94080
招聘
California Pacific Medical Center Research Institute
加利福尼亚州旧金山 94115
招聘
Kaiser Permanente - San Francisco Medical Center
加利福尼亚州旧金山 94115
招聘
Sutter Cancer Research Consortium
加利福尼亚州旧金山 94115
招聘
Kaiser Permanente - San Jose Medical Center
加利福尼亚州圣何塞 95119
招聘
Kaiser Permanente - San Leandro Medical Center
加利福尼亚州圣莱安德罗 94577
招聘
Kaiser Permanente - Santa Clara Medical Center
加利福尼亚州圣克拉拉 95051
招聘
Sutter Palo Alto Medical Foundation: Santa Cruz
Santa Cruz, California 95065
招聘
Sutter Palo Alto Medical Foundation: Fremont
Santa Cruz, California 994538
招聘
Sutter Palo Alto Medical Foundation: Sunnyvale
Sunnyvale, California 94086
招聘
Kaiser Permanente - Vallejo 医疗中心
加利福尼亚州瓦莱约 94589
招聘
Kaiser Permanente - Walnut Creek Medical Center
加利福尼亚州核桃溪 94596
招聘
Saint Vincent's Medical Center (SVMC)
Bridgeport, Connecticut 06606
招聘
Hartford Hospital
Hartford, Connecticut 06102
招聘
Midstate Medical Center (MSMC)
Meriden, Connecticut 06451
招聘
The Hospital of Central Connecticut (HOCC) Cancer Center
New Britain, Connecticut 06053
招聘
William W. Backus Hospital
Norwich, Connecticut 06360
招聘
Charlotte Hungerford
Torrington, Connecticut 06790
招聘
Windham Hospital (WH)
Willimantic, Connecticut 06226
招聘
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州阿尔塔蒙特斯普林斯 32701
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Bonita Springs, Florida 34135
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Bradenton, Florida 34211
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州布兰登 33511
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Cape Coral, Florida 33909
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州克利尔沃特 33761
活跃,非招募
Holy Cross Hospital
Fort Lauderdale, Florida 33308
招聘
Florida Cancer Specialists South / Sarah Cannon Research Institute
佛罗里达州迈尔斯堡 33901
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Fort Myers, Florida 33905
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Fort Myers, Florida 33908
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州盖恩斯维尔 32605
活跃,非招募
University of Florida Health
佛罗里达州盖恩斯维尔 32610
招聘
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州拉戈 33770
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州莱坎托 34461
活跃,非招募
University of Miami Sylvester Comprehensive Cancer Center
佛罗里达州迈阿密 33136
招聘
Florida Cancer Specialists South / Sarah Cannon Research Institute
Naples, Florida 34102
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州奥卡拉 34474
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州奥兰治市 32763
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州奥兰多 32806
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Port Charlotte, Florida 33980
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州圣彼得堡 33705
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
佛罗里达州萨拉索塔 34232
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Sarasota, Florida 34236
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州坦帕 33607
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州塔瓦雷斯 32778
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
The Villages, Florida 32159
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州特里尼蒂 34655
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Venice, Florida 34285
活跃,非招募
Florida Cancer Specialists South / Sarah Cannon Research Institute
Venice, Florida 34292
活跃,非招募
Florida Cancer Specialists North / Sarah Cannon Research Institute
佛罗里达州温特公园 32789
活跃,非招募
Cancer Treatment Centers of America - Atlanta
Atlanta, Georgia 30265
招聘
Emory University Winship Cancer Institute
佐治亚州亚特兰大 30322
招聘
Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion
Savannah, Georgia 31405
招聘
Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute
Savannah, Georgia 31405
招聘
Lewis Cancer & Research Pavilion
Savannah, Georgia 31405
招聘
Summit Cancer Care
Savannah, Georgia 31405
招聘
The Queen's Medical Center (The University of Texas MD Anderson Cancer Center)
夏威夷州檀香山 96813
活跃,非招募
Cancer Treatment Centers of America-Chicago
Chicago, Illinois 60099
招聘
Community Health Network (The University of Texas MD Anderson Cancer Center)
Indianapolis, Indiana 46250
招聘
Harold Alfond Center for Cancer Care
Augusta, Maine 04330
招聘
Jackson Laboratory - Maine Cancer Genomics Initiative
Augusta, Maine 04330
招聘
Waldo County General Hospital
Belfast, Maine 04915
招聘
SMHC Cancer Care and Blood Disorders -Biddeford
缅因州比迪福德 04005
招聘
Northern Light Cancer Care
Brewer, Maine 04412
招聘
Raish Peavey Haskell Children's Cancer and Treatment Center
Brewer, Maine 04412
招聘
MaineHealth Cancer Care -Brunswick
Brunswick, Maine 04011
招聘
New England Cancer Specialist
Kennebunk, Maine 04043
招聘
York Hopsital Oncology & Infusion Care in Kittery
Kittery, Maine 03904
招聘
Stephens Memorial Hospital
Norway, Maine 04268
招聘
Penobscot Bay Medical Center
Rockport, Maine 04856
招聘
SMHC Cancer Care and Blood Disorders -Sandford
Sanford, Maine 04073
招聘
Maine Children's Cancer Program
缅因州斯卡布罗 04074
招聘
Maine Medical Partner's Women's Health
缅因州斯卡布罗 04074
招聘
New England Cancer Specialist
缅因州斯卡布罗 04074
招聘
MaineHealth Cancer Care -South Portland
South Portland, Maine 04106
招聘
New England Cancer Specialist
Topsham, Maine 04086
招聘
York Hospital Oncology & Infusion Care in Wells
Wells, Maine 04090
招聘
York Hospital Oncology & Infusion Care in York
York, Maine 03909
招聘
Trinity Health Ann Arbor Hospital
密歇根州安阿伯市 48106
招聘
密歇根大学
密歇根州安阿伯 48109
招聘
Ascension St. John Hospital
Detroit, Michigan 48236
招聘
基因赫利癌症研究所
Grand Blanc, Michigan 48439
招聘
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan 49503
招聘
Sparrow Hospital
密歇根州兰辛 48912
招聘
Trinity Health Livonia Hospital
密歇根州利沃尼亚 48154
招聘
Trinity Health Oakland Hospital
Pontiac, Michigan 48341
招聘
Ascension St. Mary's Hospital
Saginaw, Michigan 48601
招聘
Michigan Cancer Research Consortium
Traverse City, Michigan 48341
招聘
St. John Macomb Oakland Hospital
Warren, Michigan 48093
招聘
内布拉斯加大学医学中心
内布拉斯加州奥马哈 68198
招聘
NH Oncology - Hematology, PA
Concord, New Hampshire 03103
招聘
Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
招聘
New England Cancer Specialist
Portsmouth, New Hampshire 03801
招聘
Lovelace Medical Center - Saint Joseph Square
Albuquerque, New Mexico 87102
招聘
Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
招聘
The University of New Mexico Comprehensive Cancer Center
新墨西哥州阿尔伯克基 87131
招聘
Memorial Medical Center
Las Cruces, New Mexico 88011
招聘
Presbyterian Rust Medical Center
Rio Rancho, New Mexico 87124
招聘
Northwell Health Monter Cancer Center
纽约州成功湖 11042
招聘
北韦斯特切斯特医院
纽约州基斯科山 10549
招聘
Cohen Children's Medical Center
New Hyde Park, New York 11040
招聘
Herbert Irving Comprehensive Cancer Center
纽约州纽约市 10032
招聘
Manhattan Eye, Ear, and Throat Hospital
纽约州纽约市 10065
招聘
Staten Island University Hospital
New York, New York 10305
招聘
Phelps Hospital
Sleepy Hollow, New York 10591
招聘
Lineberger Comprehensive Cancer Center
北卡罗来纳州教堂山 27599
招聘
Atrium Health's Levine Cancer Institute
Charlotte, North Carolina 28277
招聘
Sanford Health- Bismarck
北达科他州俾斯麦 58501
招聘
Sanford Health- Fargo
北达科他州法戈 58122
招聘
University of Cincinnati Medical Center
俄亥俄州辛辛那提 45219
招聘
Kettering Health
俄亥俄州凯特林 45429
招聘
West Chester Hospital
West Chester, Ohio 45069
招聘
Providence Health & Services
俄勒冈州波特兰 97213
招聘
Lehigh Valley Health Network
宾夕法尼亚州阿伦敦 18103
招聘
Lehigh Valley Hospital- Muhlenberg
宾夕法尼亚州伯利恒 18017
招聘
Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
招聘
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
招聘
福克斯蔡斯癌症中心
Philadelphia, Pennsylvania 19111
招聘
SC Cancer Specialists at St. Joseph's/Candler Bluffton
Bluffton, South Carolina 29910
招聘
St. Joseph's/Candler Smith
Bluffton, South Carolina 29910
招聘
Summit Cancer Care at St. Josph's/Candler Bluffton
Bluffton, South Carolina 29910
招聘
South Carolina Cancer Specialists
Hilton Head Island, South Carolina 29926
招聘
Sanford Cancer Center Oncology Clinic and Pharmacy
南达科他州苏福尔斯 57104
招聘
Tennessee Oncology - Nashville / Sarah Cannon Research Institute
田纳西州纳什维尔 37203
招聘
得克萨斯大学 MD 安德森癌症中心
德克萨斯州休斯顿 77030
招聘
Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center
Cedar City, Utah 84720
招聘
Dixie Regional Medical Center-River Road Campus
Saint George, Utah 84770
招聘
Intermountain Healthcare
Salt Lake City, Utah 84107
招聘
Inova Schar Cancer Institute
Fairfax, Virginia 22042
招聘
Swedish Cancer Institute
Seattle, Washington 98104
招聘
Aurora Cancer Care - Burlington
Burlington, Wisconsin 53105
招聘
Aurora Health Care - Germantown Health Center
Germantown, Wisconsin 53022
招聘
Aurora Cancer Care - Grafton
Grafton, Wisconsin 53024
招聘
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
招聘
Aurora Cancer Care - Kenosha South
Kenosha, Wisconsin 53142
招聘
Aurora Bay Area Medical Center
Marinette, Wisconsin 54143
招聘
Aurora Cancer Care Milwaukee
Milwaukee, Wisconsin 53209
招聘
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
招聘
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53223
招聘
Aurora West Allis Medical Center
Milwaukee, Wisconsin 53227
招聘
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
招聘
Aurora Cancer Care - Racine
Racine, Wisconsin 53406
招聘
Vince Lombardi Cancer Center
Sheboygan, Wisconsin 53081
招聘
Aurora Medical Center in Summit
Summit, Wisconsin 53066
招聘
Vince Lombardi Cancer Clinic - Two Rivers
Two Rivers, Wisconsin 54241
招聘
Aurora Cancer Care - Milwaukee West
Wauwatosa, Wisconsin 53226
招聘

联系方式

Pam Mangat, MS
联系
www.tapur.org tapur@asco.org

纳入标准

纳入标准

* 12 years of age or older (*Restrictions apply. Not all therapies are available for patients 9.0 g/dl
3. Platelets > 75,000/µl
4. Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome
5. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases)
6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
* Patients must have disease that can be objectively measured by physical or radiographic exam (per RECIST v1.1 for solid tumor, Lugano criteria for non-Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only, bone-only disease without an identifiable soft tissue component, or patients with only assessable non-measurable disease) are NOT eligible.
* Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited or New York State accredited (for labs offering services to residents of NY) laboratory. Labs that have registered the test with the NIH Genetic Testing Registry or that provide a report that has been designated as optimized for TAPUR participation are preferred, but not required. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.
* Ability to understand and the willingness to sign a written informed consent/assent document.
* Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol.
* For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
* Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and for a specified amount of time the last dose of study drug, or completely abstain from sexual intercourse.

Note: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have measurable and evaluable disease per RECIST v1.1.

排除标准

排除标准:

* Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible
* Patients with primary brain tumors or leptomeningeal metastases are excluded.
* Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.
* Patients with known progressive brain metastases are eligible but additional eligibility criteria apply.

Note: there are additional exclusion criteria that may apply

NCT ID

NCT02693535

添加审判日期

2016-02-26

更新日期

2025-01-29