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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

2026-09-22

Healthy Volunteers

Conditions

Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors

Interventions

DRUG

Sunitinib (CLOSED TO ENROLLMENT)

drug

DRUG

Trastuzumab and Pertuzumab (CLOSED TO ENROLLMENT)

drug

DRUG

Vemurafenib and Cobimetinib (CLOSED TO ENROLLMENT)

drug

DRUG

Olaparib (CLOSED TO ENROLLMENT)

drug

DRUG

Nivolumab and Ipilimumab (CLOSED TO ENROLLMENT)

drug

DRUG

Abemaciclib (CLOSED TO ENROLLMENT)

drug

DRUG

Talazoparib (CLOSED TO ENROLLMENT)

drug

DRUG

Atezolizumab and Talazoparib (CLOSED TO ENROLLMENT)

drug

DRUG

Tucatinib plus Trastuzumab Subcutaneous (SC) (CLOSED TO ENROLLMENT)

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 (except under the circumstance in which the TAPUR arm is designed to provide additional evidence to support an existing FDA indication). * 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 ≥ 1500 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, laboratory 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). * 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 treatment, 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 or previously treated leptomeningeal disease are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 1 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 (181)

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

And 81 more locations on ClinicalTrials.gov

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 (181)