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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
NCT02693535 · American Society of Clinical Oncology
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Targeted Agent and Profiling Utilization Registry (TAPUR) Study
About this study
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
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
Study design
Enrollment target: 4200 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2016-03-14
Estimated completion: 2028-12-31
Last updated: 2026-04-02
Interventions
Drug: PalbociclibDrug: SunitinibDrug: TemsirolimusDrug: Trastuzumab and PertuzumabDrug: Vemurafenib and CobimetinibDrug: RegorafenibDrug: OlaparibDrug: Nivolumab and IpilimumabDrug: AbemaciclibDrug: TalazoparibDrug: Atezolizumab and TalazoparibDrug: Tucatinib plus Trastuzumab Subcutaneous (SC)Drug: FutibatinibDrug: Dabrafenib plus TrametinibDrug: Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
Primary outcomes
- • Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria (Assessed at 16 weeks of treatment)
Sponsor
American Society of Clinical Oncology · other
With: AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Inc., Pfizer, Taiho Oncology, Inc., Novartis, Merck Institute for Therapeutic Research, Boehringer Ingelheim, Seattle Genetics (now a wholly owned subsidiary of Pfizer)
Contacts & investigators
ContactPam Mangat, MS · contact · tapur@asco.org · www.tapur.org
All locations (174)
University of Alabama at Birmingham Comprehensive Cancer CenterRecruiting
Birmingham, Alabama, United States
Cancer Treatment Centers of America-PhoenixRecruiting
Phoenix, Arizona, United States
Sutter AuburnRecruiting
Auburn, California, United States
Sutter Alta BatesRecruiting
Berkeley, California, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateRecruiting
Los Angeles, California, United States
Kaiser Permanente - Oakland Medical CenterRecruiting
Oakland, California, United States
Sutter Palo Alto Medical Foundation: Palo AltoRecruiting
Palo Alto, California, United States
Kaiser Permanente - Roseville Medical CenterRecruiting
Roseville, California, United States
Sutter RosevilleRecruiting
Roseville, California, United States
Kaiser Permanente - Sacramento Medical CenterRecruiting
Sacramento, California, United States
Sutter SacramentoRecruiting
Sacramento, California, United States
Kaiser Permanente - South San Francisco Medical CenterRecruiting
San Francisco, California, United States
California Pacific Medical Center Research InstituteRecruiting
San Francisco, California, United States
Kaiser Permanente - San Francisco Medical CenterRecruiting
San Francisco, California, United States
Sutter Cancer Research ConsortiumRecruiting
San Francisco, California, United States
Kaiser Permanente - San Jose Medical CenterRecruiting
San Jose, California, United States
Kaiser Permanente - San Leandro Medical CenterRecruiting
San Leandro, California, United States
Sutter Sansum ClinicRecruiting
Santa Barbara, California, United States
Kaiser Permanente - Santa Clara Medical CenterRecruiting
Santa Clara, California, United States
Sutter Palo Alto Medical Foundation: Santa CruzRecruiting
Santa Cruz, California, United States
Sutter Palo Alto Medical Foundation: FremontRecruiting
Santa Cruz, California, United States
Sutter Palo Alto Medical Foundation: SunnyvaleRecruiting
Sunnyvale, California, United States
Kaiser Permanente - Vallejo Medical CenterRecruiting
Vallejo, California, United States
Kaiser Permanente - Walnut Creek Medical CenterRecruiting
Walnut Creek, California, United States
Saint Vincent's Medical Center (SVMC)Recruiting
Bridgeport, Connecticut, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Midstate Medical Center (MSMC)Recruiting
Meriden, Connecticut, United States
The Hospital of Central Connecticut (HOCC) Cancer CenterRecruiting
New Britain, Connecticut, United States
William W. Backus HospitalRecruiting
Norwich, Connecticut, United States
Charlotte HungerfordRecruiting
Torrington, Connecticut, United States
Windham Hospital (WH)Recruiting
Willimantic, Connecticut, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Altamonte Springs, Florida, United States
University of Miami/Sylvester Cancer Institute - AventuraRecruiting
Aventura, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Bonita Springs, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Bradenton, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Brandon, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Cape Coral, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Clearwater, Florida, United States
University of Miami/Sylvester Cancer Institute - LennarRecruiting
Coral Gables, Florida, United States
University of Miami/Sylvester Cancer Institute - Deerfield BeachRecruiting
Deerfield Beach, Florida, United States
Holy Cross HospitalRecruiting
Fort Lauderdale, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Fort Myers, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Fort Myers, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Fort Myers, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Gainesville, Florida, United States
University of Florida HealthRecruiting
Gainesville, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Largo, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Lecanto, Florida, United States
University of Miami Sylvester Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
University of Miami/Sylvester Cancer Institute - Alex's PlaceRecruiting
Miami, Florida, United States
University of Miami/Sylvester Cancer Institute - Griffin Cancer Research BuildingRecruiting
Miami, Florida, United States
University of Miami/Sylvester Cancer Institute - KendallRecruiting
Miami, Florida, United States
University of Miami/Sylvester Cancer Institute - Sole MiaRecruiting
Miami, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Naples, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Ocala, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Orange City, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Orlando, Florida, United States
University of Miami/Sylvester Cancer Institute - PlantationRecruiting
Plantation, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Port Charlotte, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Sarasota, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Sarasota, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Tampa, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Tavares, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
The Villages, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Trinity, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Venice, Florida, United States
Florida Cancer Specialists South / Sarah Cannon Research InstituteActive Not Recruiting
Venice, Florida, United States
Florida Cancer Specialists North / Sarah Cannon Research InstituteActive Not Recruiting
Winter Park, Florida, United States
Cancer Treatment Centers of America - AtlantaRecruiting
Atlanta, Georgia, United States
Emory University Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research PavilionRecruiting
Savannah, Georgia, United States
Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma InstituteRecruiting
Savannah, Georgia, United States
Lewis Cancer & Research PavilionRecruiting
Savannah, Georgia, United States
Summit Cancer CareRecruiting
Savannah, Georgia, United States
The Queen's Medical Center - POB IRecruiting
Honolulu, Hawaii, United States
The Queen's Medical Center - PunchbowlRecruiting
Honolulu, Hawaii, United States
The Queen's Medical Center - KuakiniRecruiting
Honolulu, Hawaii, United States
The Queen's Medical Center - West OahuRecruiting
‘Ewa Beach, Hawaii, United States
Cancer Treatment Centers of America-ChicagoRecruiting
Chicago, Illinois, United States
Community Health Network (The University of Texas MD Anderson Cancer Center)Recruiting
Indianapolis, Indiana, United States
Harold Alfond Center for Cancer CareRecruiting
Augusta, Maine, United States
Jackson Laboratory - Maine Cancer Genomics InitiativeRecruiting
Augusta, Maine, United States
Waldo County General HospitalRecruiting
Belfast, Maine, United States
SMHC Cancer Care and Blood Disorders -BiddefordRecruiting
Biddeford, Maine, United States
Northern Light Cancer CareRecruiting
Brewer, Maine, United States
Raish Peavey Haskell Children's Cancer and Treatment CenterRecruiting
Brewer, Maine, United States
MaineHealth Cancer Care -BrunswickRecruiting
Brunswick, Maine, United States
New England Cancer SpecialistRecruiting
Kennebunk, Maine, United States
York Hopsital Oncology & Infusion Care in KitteryRecruiting
Kittery, Maine, United States
Stephens Memorial HospitalRecruiting
Norway, Maine, United States
Penobscot Bay Medical CenterRecruiting
Rockport, Maine, United States
SMHC Cancer Care and Blood Disorders -SandfordRecruiting
Sanford, Maine, United States
Maine Children's Cancer ProgramRecruiting
Scarborough, Maine, United States
Maine Medical Partner's Women's HealthRecruiting
Scarborough, Maine, United States
New England Cancer SpecialistRecruiting
Scarborough, Maine, United States
MaineHealth Cancer Care -South PortlandRecruiting
South Portland, Maine, United States
New England Cancer SpecialistRecruiting
Topsham, Maine, United States
York Hospital Oncology & Infusion Care in WellsRecruiting
Wells, Maine, United States
York Hospital Oncology & Infusion Care in YorkRecruiting
York Village, Maine, United States
Trinity Health Ann Arbor HospitalRecruiting
Ann Arbor, Michigan, United States
University of MichiganActive Not Recruiting
Ann Arbor, Michigan, United States
Henry Ford Health Saint John HospitalRecruiting
Detroit, Michigan, United States
Genesys Hurley Cancer InstituteRecruiting
Flint, Michigan, United States
Cancer Research Consortium of West MichiganRecruiting
Grand Rapids, Michigan, United States
University of Michigan Health - Sparrow LansingRecruiting
Lansing, Michigan, United States
Trinity Health Livonia HospitalRecruiting
Livonia, Michigan, United States
Trinity Health Oakland HospitalRecruiting
Pontiac, Michigan, United States
MyMichigan Medical Center SaginawRecruiting
Saginaw, Michigan, United States
Michigan Cancer Research ConsortiumRecruiting
Traverse City, Michigan, United States
Henry Ford Health Warren HospitalRecruiting
Warren, Michigan, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
NH Oncology - Hematology, PARecruiting
Concord, New Hampshire, United States
Solinsky Center for Cancer CareRecruiting
Manchester, New Hampshire, United States
New England Cancer SpecialistRecruiting
Portsmouth, New Hampshire, United States
Lovelace Medical Center - Saint Joseph SquareRecruiting
Albuquerque, New Mexico, United States
Presbyterian Kaseman HospitalRecruiting
Albuquerque, New Mexico, United States
The University of New Mexico Comprehensive Cancer CenterRecruiting
Albuquerque, New Mexico, United States
Memorial Medical CenterRecruiting
Las Cruces, New Mexico, United States
Presbyterian Rust Medical CenterRecruiting
Rio Rancho, New Mexico, United States
Northwell Health Monter Cancer CenterRecruiting
Lake Success, New York, United States
Northern Westchester HospitalRecruiting
Mount Kisco, New York, United States
Cohen Children's Medical CenterRecruiting
New Hyde Park, New York, United States
Manhattan Eye, Ear, and Throat HospitalRecruiting
New York, New York, United States
Staten Island University HospitalRecruiting
New York, New York, United States
Queens Cancer CenterRecruiting
Rego Park, New York, United States
Phelps HospitalRecruiting
Sleepy Hollow, New York, United States
Lineberger Comprehensive Cancer CenterRecruiting
Chapel Hill, North Carolina, United States
Atrium Health's Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Sanford Health- BismarckRecruiting
Bismarck, North Dakota, United States
Sanford Health- FargoRecruiting
Fargo, North Dakota, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Kettering HealthRecruiting
Kettering, Ohio, United States
West Chester HospitalRecruiting
West Chester, Ohio, United States
Providence Health & ServicesRecruiting
Portland, Oregon, United States
Lehigh Valley Hospital - Cedar CrestRecruiting
Allentown, Pennsylvania, United States
Lehigh Valley Hospital- MuhlenbergRecruiting
Bethlehem, Pennsylvania, United States
Pocono Medical CenterRecruiting
East Stroudsburg, Pennsylvania, United States
Lehigh Valley Hospital-HazletonRecruiting
Hazleton, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
SC Cancer Specialists at St. Joseph's/Candler BlufftonRecruiting
Bluffton, South Carolina, United States
St. Joseph's/Candler SmithRecruiting
Bluffton, South Carolina, United States
Summit Cancer Care at St. Josph's/Candler BlufftonRecruiting
Bluffton, South Carolina, United States
South Carolina Cancer SpecialistsRecruiting
Hilton Head Island, South Carolina, United States
Sanford Cancer Center Oncology Clinic and PharmacyRecruiting
Sioux Falls, South Dakota, United States
Tennessee Oncology - Nashville / Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer CenterRecruiting
Cedar City, Utah, United States
Intermountain HealthcareRecruiting
Salt Lake City, Utah, United States
Dixie Regional Medical Center-River Road CampusRecruiting
St. George, Utah, United States
Inova Schar Cancer InstituteRecruiting
Fairfax, Virginia, United States
Northwest Medical SpecialtiesRecruiting
Bonney Lake, Washington, United States
Northwest Medical SpecialtiesRecruiting
Federal Way, Washington, United States
Northwest Medical SpecialtiesRecruiting
Gig Harbor, Washington, United States
Northwest Medical SpecialtiesRecruiting
Olympia, Washington, United States
Northwest Medical SpecialtiesRecruiting
Puyallup, Washington, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Northwest Medical SpecialtiesRecruiting
Tacoma, Washington, United States
Aurora Cancer Care - BurlingtonRecruiting
Burlington, Wisconsin, United States
Aurora Health Care - Germantown Health CenterRecruiting
Germantown, Wisconsin, United States
Aurora Cancer Care - GraftonRecruiting
Grafton, Wisconsin, United States
Aurora BayCare Medical CenterRecruiting
Green Bay, Wisconsin, United States
Aurora Cancer Care - Kenosha SouthRecruiting
Kenosha, Wisconsin, United States
Aurora Bay Area Medical CenterRecruiting
Marinette, Wisconsin, United States
Aurora Cancer Care MilwaukeeRecruiting
Milwaukee, Wisconsin, United States
Aurora St. Luke's Medical CenterRecruiting
Milwaukee, Wisconsin, United States
Aurora Sinai Medical CenterRecruiting
Milwaukee, Wisconsin, United States
Aurora West Allis Medical CenterRecruiting
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - OshkoshRecruiting
Oshkosh, Wisconsin, United States
Aurora Cancer Care - RacineRecruiting
Racine, Wisconsin, United States
Vince Lombardi Cancer CenterRecruiting
Sheboygan, Wisconsin, United States
Aurora Medical Center in SummitRecruiting
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic - Two RiversRecruiting
Two Rivers, Wisconsin, United States
Aurora Cancer Care - Milwaukee WestRecruiting
Wauwatosa, Wisconsin, United States