Last updated: 2024-08-22
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.
Lymphoma, Non-Hodgkin
Multiple Myeloma
Advanced Solid Tumors
Palbociclib
Sunitinib
Temsirolimus
Trastuzumab and Pertuzumab
Vemurafenib and Cobimetinib
Regorafenib
Olaparib
Pembrolizumab
Nivolumab and Ipilimumab
Abemaciclib
Talazoparib
Atezolizumab and PHESGO
Atezolizumab and Talazoparib
Entrectinib
Larotrectinib
Tucatinib plus Trastuzumab Subcutaneous (SC)
Futibatinib
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 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
Gender: ALL
Age: 12+
Healthy Volunteers: No
University of Alabama at Birmingham Comprehensive Cancer Center
Cancer Treatment Centers of America-Phoenix
Sutter Auburn
Sutter Alta Bates
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Kaiser Permanente - Oakland Medical Center
Sutter Palo Alto Medical Foundation: Palo Alto
Kaiser Permanente - Roseville Medical Center
Sutter Roseville
Kaiser Permanente - Sacramento Medical Center
Sutter Sacramento
Kaiser Permanente - South San Francisco Medical Center
California Pacific Medical Center Research Institute
Kaiser Permanente - San Francisco Medical Center
Sutter Cancer Research Consortium
Kaiser Permanente - San Jose Medical Center
Kaiser Permanente - San Leandro Medical Center
Kaiser Permanente - Santa Clara Medical Center
Sutter Palo Alto Medical Foundation: Santa Cruz
Sutter Palo Alto Medical Foundation: Fremont
Sutter Palo Alto Medical Foundation: Sunnyvale
Kaiser Permanente - Vallejo Medical Center
Kaiser Permanente - Walnut Creek Medical Center
Saint Vincent's Medical Center (SVMC)
Hartford Hospital
Midstate Medical Center (MSMC)
The Hospital of Central Connecticut (HOCC) Cancer Center
William W. Backus Hospital
Charlotte Hungerford
Windham Hospital (WH)
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists East / Sarah Cannon Research Institute
Holy Cross Hospital
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
University of Florida Health
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
University of Miami Sylvester Comprehensive Cancer Center
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists East / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists South / Sarah Cannon Research Institute
Florida Cancer Specialists East / Sarah Cannon Research Institute
Florida Cancer Specialists East / Sarah Cannon Research Institute
Florida Cancer Specialists East / Sarah Cannon Research Institute
Florida Cancer Specialists North / Sarah Cannon Research Institute
Cancer Treatment Centers of America - Atlanta
Emory University Winship Cancer Institute
Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion
Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute
Lewis Cancer & Research Pavilion
Summit Cancer Care
The Queen's Medical Center (The University of Texas MD Anderson Cancer Center)
Cancer Treatment Centers of America-Chicago
Community Health Network (The University of Texas MD Anderson Cancer Center)
Harold Alfond Center for Cancer Care
Jackson Laboratory - Maine Cancer Genomics Initiative
Waldo County General Hospital
SMHC Cancer Care and Blood Disorders -Biddeford
Northern Light Cancer Care
Raish Peavey Haskell Children's Cancer and Treatment Center
MaineHealth Cancer Care -Brunswick
New England Cancer Specialist
York Hopsital Oncology & Infusion Care in Kittery
Stephens Memorial Hospital
Penobscot Bay Medical Center
SMHC Cancer Care and Blood Disorders -Sandford
Maine Children's Cancer Program
Maine Medical Partner's Women's Health
New England Cancer Specialist
MaineHealth Cancer Care -South Portland
New England Cancer Specialist
York Hospital Oncology & Infusion Care in Wells
York Hospital Oncology & Infusion Care in York
Trinity Health Ann Arbor Hospital
University of Michigan
Ascension St. John Hospital
Genesys Hurley Cancer Institute
Cancer Research Consortium of West Michigan
Sparrow Hospital
Trinity Health Livonia Hospital
Trinity Health Oakland Hospital
Ascension St. Mary's Hospital
Michigan Cancer Research Consortium
St. John Macomb Oakland Hospital
University of Nebraska Medical Center
NH Oncology - Hematology, PA
Solinsky Center for Cancer Care
New England Cancer Specialist
Lovelace Medical Center - Saint Joseph Square
Presbyterian Kaseman Hospital
The University of New Mexico Comprehensive Cancer Center
Memorial Medical Center
Presbyterian Rust Medical Center
Northwell Health Monter Cancer Center
Cohen Children's Medical Center
Herbert Irving Comprehensive Cancer Center
Manhattan Eye, Ear, and Throat Hospital
Staten Island University Hospital
Phelps Hospital
Lineberger Comprehensive Cancer Center
Atrium Health's Levine Cancer Institute
Sanford Health- Bismarck
Sanford Health- Fargo
University of Cincinnati Medical Center
Kettering Health
West Chester Hospital
Providence Health & Services
Lehigh Valley Health Network
Lehigh Valley Hospital- Muhlenberg
Pocono Medical Center
Lehigh Valley Hospital-Hazleton
Fox Chase Cancer Center
SC Cancer Specialists at St. Joseph's/Candler Bluffton
St. Joseph's/Candler Smith
Summit Cancer Care at St. Josph's/Candler Bluffton
South Carolina Cancer Specialists
Sanford Cancer Center Oncology Clinic and Pharmacy
Tennessee Oncology - Nashville / Sarah Cannon Research Institute
The University of Texas MD Anderson Cancer Center
Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center
Dixie Regional Medical Center-River Road Campus
Intermountain Healthcare
Inova Schar Cancer Institute
Swedish Cancer Institute
Aurora Cancer Care - Burlington
Aurora Health Care - Germantown Health Center
Aurora Cancer Care - Grafton
Aurora BayCare Medical Center
Aurora Cancer Care - Kenosha South
Aurora Bay Area Medical Center
Aurora Cancer Care Milwaukee
Aurora St. Luke's Medical Center
Aurora Sinai Medical Center
Aurora West Allis Medical Center
Vince Lombardi Cancer Clinic - Oshkosh
Aurora Cancer Care - Racine
Vince Lombardi Cancer Center
Aurora Medical Center in Summit
Vince Lombardi Cancer Clinic - Two Rivers
Aurora Cancer Care - Milwaukee West
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov