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RECRUITING

NCT02693535

PHASE2

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

Sponsor: American Society of Clinical Oncology

View on ClinicalTrials.gov

Summary

The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers). \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*

Official title: Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4200

Start Date

2016-03-14

Completion Date

2028-12-31

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors

Interventions

DRUG

Palbociclib

drug

DRUG

Sunitinib

drug

DRUG

Temsirolimus

drug

DRUG

Trastuzumab and Pertuzumab

drug

DRUG

Vemurafenib and Cobimetinib

drug

DRUG

Regorafenib

drug

DRUG

Olaparib

drug

DRUG

Nivolumab and Ipilimumab

drug

DRUG

Abemaciclib

drug

DRUG

Talazoparib

drug

DRUG

Atezolizumab and Talazoparib

drug

DRUG

Tucatinib plus Trastuzumab Subcutaneous (SC)

drug

DRUG

Futibatinib

drug

DRUG

Dabrafenib plus Trametinib

Drug

DRUG

Fam-Trastuzumab Deruxtecan-Nxki (TDxD)

Drug

Inclusion Criteria: * 12 years of age or older (\*Restrictions apply. Not all therapies are available for patients \<18) * Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated * Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG) criteria) * Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria: 1. Absolute neutrophil count ≥ 1.5 x 106/µl 2. Hemoglobin \> 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. Exclusion Criteria: * 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 new, untreated or progressive 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

Locations (174)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Cancer Treatment Centers of America-Phoenix

Phoenix, Arizona, United States

Sutter Auburn

Auburn, California, United States

Sutter Alta Bates

Berkeley, California, United States

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

Los Angeles, California, United States

Kaiser Permanente - Oakland Medical Center

Oakland, California, United States

Sutter Palo Alto Medical Foundation: Palo Alto

Palo Alto, California, United States

Kaiser Permanente - Roseville Medical Center

Roseville, California, United States

Sutter Roseville

Roseville, California, United States

Kaiser Permanente - Sacramento Medical Center

Sacramento, California, United States

Sutter Sacramento

Sacramento, California, United States

Kaiser Permanente - South San Francisco Medical Center

San Francisco, California, United States

California Pacific Medical Center Research Institute

San Francisco, California, United States

Kaiser Permanente - San Francisco Medical Center

San Francisco, California, United States

Sutter Cancer Research Consortium

San Francisco, California, United States

Kaiser Permanente - San Jose Medical Center

San Jose, California, United States

Kaiser Permanente - San Leandro Medical Center

San Leandro, California, United States

Sutter Sansum Clinic

Santa Barbara, California, United States

Kaiser Permanente - Santa Clara Medical Center

Santa Clara, California, United States

Sutter Palo Alto Medical Foundation: Santa Cruz

Santa Cruz, California, United States

Sutter Palo Alto Medical Foundation: Fremont

Santa Cruz, California, United States

Sutter Palo Alto Medical Foundation: Sunnyvale

Sunnyvale, California, United States

Kaiser Permanente - Vallejo Medical Center

Vallejo, California, United States

Kaiser Permanente - Walnut Creek Medical Center

Walnut Creek, California, United States

Saint Vincent's Medical Center (SVMC)

Bridgeport, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Midstate Medical Center (MSMC)

Meriden, Connecticut, United States

The Hospital of Central Connecticut (HOCC) Cancer Center

New Britain, Connecticut, United States

William W. Backus Hospital

Norwich, Connecticut, United States

Charlotte Hungerford

Torrington, Connecticut, United States

Windham Hospital (WH)

Willimantic, Connecticut, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Altamonte Springs, Florida, United States

University of Miami/Sylvester Cancer Institute - Aventura

Aventura, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Bonita Springs, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Bradenton, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Brandon, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Cape Coral, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Clearwater, Florida, United States

University of Miami/Sylvester Cancer Institute - Lennar

Coral Gables, Florida, United States

University of Miami/Sylvester Cancer Institute - Deerfield Beach

Deerfield Beach, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Gainesville, Florida, United States

University of Florida Health

Gainesville, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Largo, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Lecanto, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

University of Miami/Sylvester Cancer Institute - Alex's Place

Miami, Florida, United States

University of Miami/Sylvester Cancer Institute - Griffin Cancer Research Building

Miami, Florida, United States

University of Miami/Sylvester Cancer Institute - Kendall

Miami, Florida, United States

University of Miami/Sylvester Cancer Institute - Sole Mia

Miami, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Naples, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Ocala, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Orange City, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Orlando, Florida, United States

University of Miami/Sylvester Cancer Institute - Plantation

Plantation, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Port Charlotte, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Sarasota, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Sarasota, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

St. Petersburg, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Tampa, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Tavares, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

The Villages, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Trinity, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Venice, Florida, United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Venice, Florida, United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Winter Park, Florida, United States

Cancer Treatment Centers of America - Atlanta

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion

Savannah, Georgia, United States

Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute

Savannah, Georgia, United States

Lewis Cancer & Research Pavilion

Savannah, Georgia, United States

Summit Cancer Care

Savannah, Georgia, United States

The Queen's Medical Center - POB I

Honolulu, Hawaii, United States

The Queen's Medical Center - Punchbowl

Honolulu, Hawaii, United States

The Queen's Medical Center - Kuakini

Honolulu, Hawaii, United States

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, United States

Cancer Treatment Centers of America-Chicago

Chicago, Illinois, United States

Community Health Network (The University of Texas MD Anderson Cancer Center)

Indianapolis, Indiana, United States

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Jackson Laboratory - Maine Cancer Genomics Initiative

Augusta, Maine, United States

Waldo County General Hospital

Belfast, Maine, United States

SMHC Cancer Care and Blood Disorders -Biddeford

Biddeford, Maine, United States

Northern Light Cancer Care

Brewer, Maine, United States

Raish Peavey Haskell Children's Cancer and Treatment Center

Brewer, Maine, United States

MaineHealth Cancer Care -Brunswick

Brunswick, Maine, United States

New England Cancer Specialist

Kennebunk, Maine, United States

York Hopsital Oncology & Infusion Care in Kittery

Kittery, Maine, United States

Stephens Memorial Hospital

Norway, Maine, United States

Penobscot Bay Medical Center

Rockport, Maine, United States

SMHC Cancer Care and Blood Disorders -Sandford

Sanford, Maine, United States

Maine Children's Cancer Program

Scarborough, Maine, United States

Maine Medical Partner's Women's Health

Scarborough, Maine, United States

New England Cancer Specialist

Scarborough, Maine, United States

MaineHealth Cancer Care -South Portland

South Portland, Maine, United States

New England Cancer Specialist

Topsham, Maine, United States

York Hospital Oncology & Infusion Care in Wells

Wells, Maine, United States

York Hospital Oncology & Infusion Care in York

York Village, Maine, United States

Trinity Health Ann Arbor Hospital

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Livonia Hospital

Livonia, Michigan, United States

Trinity Health Oakland Hospital

Pontiac, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Michigan Cancer Research Consortium

Traverse City, Michigan, United States

Henry Ford Health Warren Hospital

Warren, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NH Oncology - Hematology, PA

Concord, New Hampshire, United States

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

New England Cancer Specialist

Portsmouth, New Hampshire, United States

Lovelace Medical Center - Saint Joseph Square

Albuquerque, New Mexico, United States

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, United States

The University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Memorial Medical Center

Las Cruces, New Mexico, United States

Presbyterian Rust Medical Center

Rio Rancho, New Mexico, United States

Northwell Health Monter Cancer Center

Lake Success, New York, United States

Northern Westchester Hospital

Mount Kisco, New York, United States

Cohen Children's Medical Center

New Hyde Park, New York, United States

Manhattan Eye, Ear, and Throat Hospital

New York, New York, United States

Staten Island University Hospital

New York, New York, United States

Queens Cancer Center

Rego Park, New York, United States

Phelps Hospital

Sleepy Hollow, New York, United States

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Atrium Health's Levine Cancer Institute

Charlotte, North Carolina, United States

Sanford Health- Bismarck

Bismarck, North Dakota, United States

Sanford Health- Fargo

Fargo, North Dakota, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Kettering Health

Kettering, Ohio, United States

West Chester Hospital

West Chester, Ohio, United States

Providence Health & Services

Portland, Oregon, United States

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, United States

Lehigh Valley Hospital- Muhlenberg

Bethlehem, Pennsylvania, United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

SC Cancer Specialists at St. Joseph's/Candler Bluffton

Bluffton, South Carolina, United States

St. Joseph's/Candler Smith

Bluffton, South Carolina, United States

Summit Cancer Care at St. Josph's/Candler Bluffton

Bluffton, South Carolina, United States

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, United States

Sanford Cancer Center Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

Tennessee Oncology - Nashville / Sarah Cannon Research Institute

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center

Cedar City, Utah, United States

Intermountain Healthcare

Salt Lake City, Utah, United States

Dixie Regional Medical Center-River Road Campus

St. George, Utah, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Northwest Medical Specialties

Bonney Lake, Washington, United States

Northwest Medical Specialties

Federal Way, Washington, United States

Northwest Medical Specialties

Gig Harbor, Washington, United States

Northwest Medical Specialties

Olympia, Washington, United States

Northwest Medical Specialties

Puyallup, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Aurora Cancer Care - Burlington

Burlington, Wisconsin, United States

Aurora Health Care - Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care - Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care - Kenosha South

Kenosha, Wisconsin, United States

Aurora Bay Area Medical Center

Marinette, Wisconsin, United States

Aurora Cancer Care Milwaukee

Milwaukee, Wisconsin, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Aurora West Allis Medical Center

Milwaukee, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care - Racine

Racine, Wisconsin, United States

Vince Lombardi Cancer Center

Sheboygan, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic - Two Rivers

Two Rivers, Wisconsin, United States

Aurora Cancer Care - Milwaukee West

Wauwatosa, Wisconsin, United States

Clinical Research Directory

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (174)