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NCT02693535PHASE2Recruiting

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

American Society of Clinical Oncology

Start Date

3/14/2016

Completion Date

12/31/2028

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. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*

Detailed Description

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.

Eligibility Criteria

Age Range: 12 years to No maximum

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

Interventions

DRUG

Palbociclib

DRUG

Sunitinib

DRUG

Temsirolimus

DRUG

Trastuzumab and Pertuzumab

DRUG

Vemurafenib and Cobimetinib

DRUG

Regorafenib

DRUG

Olaparib

DRUG

Nivolumab and Ipilimumab

DRUG

Abemaciclib

DRUG

Talazoparib

DRUG

Atezolizumab and Talazoparib

DRUG

Tucatinib plus Trastuzumab Subcutaneous (SC)

DRUG

Futibatinib

DRUG

Dabrafenib plus Trametinib

DRUG

Fam-Trastuzumab Deruxtecan-Nxki (TDxD)

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Conditions

Lymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumors

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama 35294

United States

Cancer Treatment Centers of America-Phoenix

Phoenix, Arizona 85338

United States

Sutter Auburn

Auburn, California 95602

United States

Sutter Alta Bates

Berkeley, California 94705

United States

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

Los Angeles, California 90025

United States

Kaiser Permanente - Oakland Medical Center

Oakland, California 94611

United States

Sutter Palo Alto Medical Foundation: Palo Alto

Palo Alto, California 94301

United States

Kaiser Permanente - Roseville Medical Center

Roseville, California 95661

United States

Sutter Roseville

Roseville, California 95661

United States

Kaiser Permanente - Sacramento Medical Center

Sacramento, California 95814

United States

Sutter Sacramento

Sacramento, California 95816

United States

Kaiser Permanente - South San Francisco Medical Center

San Francisco, California 94080

United States

California Pacific Medical Center Research Institute

San Francisco, California 94115

United States

Kaiser Permanente - San Francisco Medical Center

San Francisco, California 94115

United States

Sutter Cancer Research Consortium

San Francisco, California 94115

United States

Kaiser Permanente - San Jose Medical Center

San Jose, California 95119

United States

Kaiser Permanente - San Leandro Medical Center

San Leandro, California 94577

United States

Sutter Sansum Clinic

Santa Barbara, California 93105

United States

Kaiser Permanente - Santa Clara Medical Center

Santa Clara, California 95051

United States

Sutter Palo Alto Medical Foundation: Santa Cruz

Santa Cruz, California 95065

United States

Sutter Palo Alto Medical Foundation: Fremont

Santa Cruz, California 994538

United States

Sutter Palo Alto Medical Foundation: Sunnyvale

Sunnyvale, California 94086

United States

Kaiser Permanente - Vallejo Medical Center

Vallejo, California 94589

United States

Kaiser Permanente - Walnut Creek Medical Center

Walnut Creek, California 94596

United States

Saint Vincent's Medical Center (SVMC)

Bridgeport, Connecticut 06606

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Midstate Medical Center (MSMC)

Meriden, Connecticut 06451

United States

The Hospital of Central Connecticut (HOCC) Cancer Center

New Britain, Connecticut 06053

United States

William W. Backus Hospital

Norwich, Connecticut 06360

United States

Charlotte Hungerford

Torrington, Connecticut 06790

United States

Windham Hospital (WH)

Willimantic, Connecticut 06226

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Altamonte Springs, Florida 32701

United States

University of Miami/Sylvester Cancer Institute - Aventura

Aventura, Florida 33180

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Bonita Springs, Florida 34135

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Bradenton, Florida 34211

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Brandon, Florida 33511

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Cape Coral, Florida 33909

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Clearwater, Florida 33761

United States

University of Miami/Sylvester Cancer Institute - Lennar

Coral Gables, Florida 33146

United States

University of Miami/Sylvester Cancer Institute - Deerfield Beach

Deerfield Beach, Florida 33442

United States

Holy Cross Hospital

Fort Lauderdale, Florida 33308

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida 33901

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida 33905

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Fort Myers, Florida 33908

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Gainesville, Florida 32605

United States

University of Florida Health

Gainesville, Florida 32610

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Largo, Florida 33770

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Lecanto, Florida 34461

United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

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

Miami, Florida 33136

United States

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

Miami, Florida 33136

United States

University of Miami/Sylvester Cancer Institute - Kendall

Miami, Florida 33176

United States

University of Miami/Sylvester Cancer Institute - Sole Mia

Miami, Florida 33181

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Naples, Florida 34102

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Ocala, Florida 34474

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Orange City, Florida 32763

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Orlando, Florida 32806

United States

University of Miami/Sylvester Cancer Institute - Plantation

Plantation, Florida 33324

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Port Charlotte, Florida 33980

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Sarasota, Florida 34232

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Sarasota, Florida 34236

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

St. Petersburg, Florida 33701

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Tampa, Florida 33607

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Tavares, Florida 32778

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

The Villages, Florida 32159

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Trinity, Florida 34655

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Venice, Florida 34285

United States

Florida Cancer Specialists South / Sarah Cannon Research Institute

Venice, Florida 34292

United States

Florida Cancer Specialists North / Sarah Cannon Research Institute

Winter Park, Florida 32789

United States

Cancer Treatment Centers of America - Atlanta

Atlanta, Georgia 30265

United States

Emory University Winship Cancer Institute

Atlanta, Georgia 30322

United States

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

Savannah, Georgia 31405

United States

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

Savannah, Georgia 31405

United States

Lewis Cancer & Research Pavilion

Savannah, Georgia 31405

United States

Summit Cancer Care

Savannah, Georgia 31405

United States

The Queen's Medical Center - POB I

Honolulu, Hawaii 96813

United States

The Queen's Medical Center - Punchbowl

Honolulu, Hawaii 96813

United States

The Queen's Medical Center - Kuakini

Honolulu, Hawaii 96817

United States

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii 96706

United States

Cancer Treatment Centers of America-Chicago

Chicago, Illinois 60099

United States

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

Indianapolis, Indiana 46250

United States

Harold Alfond Center for Cancer Care

Augusta, Maine 04330

United States

Jackson Laboratory - Maine Cancer Genomics Initiative

Augusta, Maine 04330

United States

Waldo County General Hospital

Belfast, Maine 04915

United States

SMHC Cancer Care and Blood Disorders -Biddeford

Biddeford, Maine 04005

United States

Northern Light Cancer Care

Brewer, Maine 04412

United States

Raish Peavey Haskell Children's Cancer and Treatment Center

Brewer, Maine 04412

United States

MaineHealth Cancer Care -Brunswick

Brunswick, Maine 04011

United States

New England Cancer Specialist

Kennebunk, Maine 04043

United States

York Hopsital Oncology & Infusion Care in Kittery

Kittery, Maine 03904

United States

Stephens Memorial Hospital

Norway, Maine 04268

United States

Penobscot Bay Medical Center

Rockport, Maine 04856

United States

SMHC Cancer Care and Blood Disorders -Sandford

Sanford, Maine 04073

United States

Maine Children's Cancer Program

Scarborough, Maine 04074

United States

Maine Medical Partner's Women's Health

Scarborough, Maine 04074

United States

New England Cancer Specialist

Scarborough, Maine 04074

United States

MaineHealth Cancer Care -South Portland

South Portland, Maine 04106

United States

New England Cancer Specialist

Topsham, Maine 04086

United States

York Hospital Oncology & Infusion Care in Wells

Wells, Maine 04090

United States

York Hospital Oncology & Infusion Care in York

York Village, Maine 03909

United States

Trinity Health Ann Arbor Hospital

Ann Arbor, Michigan 48106

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Health Saint John Hospital

Detroit, Michigan 48236

United States

Genesys Hurley Cancer Institute

Flint, Michigan 48503

United States

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan 49503

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan 48912

United States

Trinity Health Livonia Hospital

Livonia, Michigan 48154

United States

Trinity Health Oakland Hospital

Pontiac, Michigan 48341

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan 48601

United States

Michigan Cancer Research Consortium

Traverse City, Michigan 48341

United States

Henry Ford Health Warren Hospital

Warren, Michigan 48093

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

NH Oncology - Hematology, PA

Concord, New Hampshire 03103

United States

Solinsky Center for Cancer Care

Manchester, New Hampshire 03103

United States

New England Cancer Specialist

Portsmouth, New Hampshire 03801

United States

Lovelace Medical Center - Saint Joseph Square

Albuquerque, New Mexico 87102

United States

Presbyterian Kaseman Hospital

Albuquerque, New Mexico 87110

United States

The University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico 87131

United States

Memorial Medical Center

Las Cruces, New Mexico 88011

United States

Presbyterian Rust Medical Center

Rio Rancho, New Mexico 87124

United States

Northwell Health Monter Cancer Center

Lake Success, New York 11042

United States

Northern Westchester Hospital

Mount Kisco, New York 10549

United States

Cohen Children's Medical Center

New Hyde Park, New York 11040

United States

Manhattan Eye, Ear, and Throat Hospital

New York, New York 10065

United States

Staten Island University Hospital

New York, New York 10305

United States

Queens Cancer Center

Rego Park, New York 11374

United States

Phelps Hospital

Sleepy Hollow, New York 10591

United States

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina 27599

United States

Atrium Health's Levine Cancer Institute

Charlotte, North Carolina 28277

United States

Sanford Health- Bismarck

Bismarck, North Dakota 58501

United States

Sanford Health- Fargo

Fargo, North Dakota 58122

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Kettering Health

Kettering, Ohio 45429

United States

West Chester Hospital

West Chester, Ohio 45069

United States

Providence Health & Services

Portland, Oregon 97213

United States

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania 18103

United States

Lehigh Valley Hospital- Muhlenberg

Bethlehem, Pennsylvania 18017

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania 18301

United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania 18201

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

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

Bluffton, South Carolina 29910

United States

St. Joseph's/Candler Smith

Bluffton, South Carolina 29910

United States

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

Bluffton, South Carolina 29910

United States

South Carolina Cancer Specialists

Hilton Head Island, South Carolina 29926

United States

Sanford Cancer Center Oncology Clinic and Pharmacy

Sioux Falls, South Dakota 57104

United States

Tennessee Oncology - Nashville / Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

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

Cedar City, Utah 84720

United States

Intermountain Healthcare

Salt Lake City, Utah 84107

United States

Dixie Regional Medical Center-River Road Campus

St. George, Utah 84770

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22042

United States

Northwest Medical Specialties

Bonney Lake, Washington 98391

United States

Northwest Medical Specialties

Federal Way, Washington 98003

United States

Northwest Medical Specialties

Gig Harbor, Washington 98332

United States

Northwest Medical Specialties

Olympia, Washington 98502

United States

Northwest Medical Specialties

Puyallup, Washington 98373

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

Northwest Medical Specialties

Tacoma, Washington 98405

United States

Aurora Cancer Care - Burlington

Burlington, Wisconsin 53105

United States

Aurora Health Care - Germantown Health Center

Germantown, Wisconsin 53022

United States

Aurora Cancer Care - Grafton

Grafton, Wisconsin 53024

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin 54311

United States

Aurora Cancer Care - Kenosha South

Kenosha, Wisconsin 53142

United States

Aurora Bay Area Medical Center

Marinette, Wisconsin 54143

United States

Aurora Cancer Care Milwaukee

Milwaukee, Wisconsin 53209

United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin 53215

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin 53223

United States

Aurora West Allis Medical Center

Milwaukee, Wisconsin 53227

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin 54904

United States

Aurora Cancer Care - Racine

Racine, Wisconsin 53406

United States

Vince Lombardi Cancer Center

Sheboygan, Wisconsin 53081

United States

Aurora Medical Center in Summit

Summit, Wisconsin 53066

United States

Vince Lombardi Cancer Clinic - Two Rivers

Two Rivers, Wisconsin 54241

United States

Aurora Cancer Care - Milwaukee West

Wauwatosa, Wisconsin 53226

United States

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