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

Multiple Myeloma Clinical Trial

— TAPUR  

Official title:

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02693535
• Other study ID #: Pro00014171
• Status: Recruiting
• Phase: Phase 2
• Start date: March 14, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: American Society of Clinical Oncology
• Contact: Pam Mangat, MS
• Phone: www.tapur.org
• Email: tapur[@]asco.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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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.

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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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3791
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma, Non-Hodgkin
• Multiple Myeloma

Intervention

Drug:
• Palbociclib
drug
• Sunitinib
drug
• Temsirolimus
drug
• Trastuzumab and Pertuzumab
drug
• Vemurafenib and Cobimetinib
drug
• Regorafenib
drug
• Olaparib
drug
• Pembrolizumab
drug
• Nivolumab and Ipilimumab
drug
• Abemaciclib
drug
• Talazoparib
drug
• Atezolizumab and PHESGO
drug
• Atezolizumab and Talazoparib
drug
• Entrectinib
drug
• Larotrectinib
drug
• Tucatinib plus Trastuzumab Subcutaneous (SC)
drug
• Futibatinib
drug

Locations

Country	Name	City	State
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	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Altamonte Springs	Florida
United States	Trinity Health Ann Arbor Hospital	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan
United States	Cancer Treatment Centers of America - Atlanta	Atlanta	Georgia
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Sutter Auburn	Auburn	California
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	Sutter Alta Bates	Berkeley	California
United States	Lehigh Valley Hospital- Muhlenberg	Bethlehem	Pennsylvania
United States	SMHC Cancer Care and Blood Disorders -Biddeford	Biddeford	Maine
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Sanford Health- Bismarck	Bismarck	North Dakota
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	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	Northern Light Cancer Care	Brewer	Maine
United States	Raish Peavey Haskell Children's Cancer and Treatment Center	Brewer	Maine
United States	Saint Vincent's Medical Center (SVMC)	Bridgeport	Connecticut
United States	MaineHealth Cancer Care -Brunswick	Brunswick	Maine
United States	Aurora Cancer Care - Burlington	Burlington	Wisconsin
United States	Florida Cancer Specialists South / Sarah Cannon Research Institute	Cape Coral	Florida
United States	Cedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center	Cedar City	Utah
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Atrium Health's Levine Cancer Institute	Charlotte	North Carolina
United States	Cancer Treatment Centers of America-Chicago	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Clearwater	Florida
United States	NH Oncology - Hematology, PA	Concord	New Hampshire
United States	Florida Cancer Specialists East / Sarah Cannon Research Institute	Daytona Beach	Florida
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Pocono Medical Center	East Stroudsburg	Pennsylvania
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Sanford Health- Fargo	Fargo	North Dakota
United States	Florida Cancer Specialists Panhandle / Sarah Cannon Research Institute	Fleming Island	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	Aurora Health Care - Germantown Health Center	Germantown	Wisconsin
United States	Aurora Cancer Care - Grafton	Grafton	Wisconsin
United States	Genesys Hurley Cancer Institute	Grand Blanc	Michigan
United States	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Hartford Hospital	Hartford	Connecticut
United States	Lehigh Valley Hospital-Hazleton	Hazleton	Pennsylvania
United States	South Carolina Cancer Specialists	Hilton Head Island	South Carolina
United States	The Queen's Medical Center (The University of Texas MD Anderson Cancer Center)	Honolulu	Hawaii
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Community Health Network (The University of Texas MD Anderson Cancer Center)	Indianapolis	Indiana
United States	New England Cancer Specialist	Kennebunk	Maine
United States	Aurora Cancer Care - Kenosha South	Kenosha	Wisconsin
United States	Kettering Health	Kettering	Ohio
United States	York Hopsital Oncology & Infusion Care in Kittery	Kittery	Maine
United States	Northwell Health Monter Cancer Center	Lake Success	New York
United States	Sparrow Hospital	Lansing	Michigan
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Largo	Florida
United States	Memorial Medical Center	Las Cruces	New Mexico
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Lecanto	Florida
United States	Trinity Health Livonia Hospital	Livonia	Michigan
United States	The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate	Los Angeles	California
United States	Solinsky Center for Cancer Care	Manchester	New Hampshire
United States	Aurora Bay Area Medical Center	Marinette	Wisconsin
United States	Midstate Medical Center (MSMC)	Meriden	Connecticut
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Aurora Cancer Care Milwaukee	Milwaukee	Wisconsin
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Aurora West Allis Medical Center	Milwaukee	Wisconsin
United States	Florida Cancer Specialists South / Sarah Cannon Research Institute	Naples	Florida
United States	Tennessee Oncology - Nashville / Sarah Cannon Research Institute	Nashville	Tennessee
United States	The Hospital of Central Connecticut (HOCC) Cancer Center	New Britain	Connecticut
United States	Cohen Children's Medical Center	New Hyde Park	New York
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Manhattan Eye, Ear, and Throat Hospital	New York	New York
United States	Stephens Memorial Hospital	Norway	Maine
United States	William W. Backus Hospital	Norwich	Connecticut
United States	Kaiser Permanente - Oakland Medical Center	Oakland	California
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Ocala	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
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	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin
United States	Sutter Palo Alto Medical Foundation: Palo Alto	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Cancer Treatment Centers of America-Phoenix	Phoenix	Arizona
United States	Trinity Health Oakland Hospital	Pontiac	Michigan
United States	Florida Cancer Specialists South / Sarah Cannon Research Institute	Port Charlotte	Florida
United States	Providence Health & Services	Portland	Oregon
United States	New England Cancer Specialist	Portsmouth	New Hampshire
United States	Aurora Cancer Care - Racine	Racine	Wisconsin
United States	Presbyterian Rust Medical Center	Rio Rancho	New Mexico
United States	Penobscot Bay Medical Center	Rockport	Maine
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	Ascension St. Mary's Hospital	Saginaw	Michigan
United States	Dixie Regional Medical Center-River Road Campus	Saint George	Utah
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Saint Petersburg	Florida
United States	Intermountain Healthcare	Salt Lake City	Utah
United States	California Pacific Medical Center Research Institute	San Francisco	California
United States	Kaiser Permanente - San Francisco Medical Center	San Francisco	California
United States	Kaiser Permanente - South 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	SMHC Cancer Care and Blood Disorders -Sandford	Sanford	Maine
United States	Kaiser Permanente - Santa Clara Medical Center	Santa Clara	California
United States	Sutter Palo Alto Medical Foundation: Fremont	Santa Cruz	California
United States	Sutter Palo Alto Medical Foundation: Santa Cruz	Santa Cruz	California
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	Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion	Savannah	Georgia
United States	Lewis Cancer & Research Pavilion	Savannah	Georgia
United States	Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute	Savannah	Georgia
United States	Summit Cancer Care	Savannah	Georgia
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	Swedish Cancer Institute	Seattle	Washington
United States	Vince Lombardi Cancer Center	Sheboygan	Wisconsin
United States	Sanford Cancer Center Oncology Clinic and Pharmacy	Sioux Falls	South Dakota
United States	Phelps Hospital	Sleepy Hollow	New York
United States	MaineHealth Cancer Care -South Portland	South Portland	Maine
United States	Florida Cancer Specialists East / Sarah Cannon Research Institute	Stuart	Florida
United States	Aurora Medical Center in Summit	Summit	Wisconsin
United States	Sutter Palo Alto Medical Foundation: Sunnyvale	Sunnyvale	California
United States	Florida Cancer Specialists Panhandle / Sarah Cannon Research Institute	Tallahassee	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	New England Cancer Specialist	Topsham	Maine
United States	Charlotte Hungerford	Torrington	Connecticut
United States	Michigan Cancer Research Consortium	Traverse City	Michigan
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Trinity	Florida
United States	Vince Lombardi Cancer Clinic - Two Rivers	Two Rivers	Wisconsin
United States	Kaiser Permanente - Vallejo Medical Center	Vallejo	California
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 East / Sarah Cannon Research Institute	Vero Beach	Florida
United States	Kaiser Permanente - Walnut Creek Medical Center	Walnut Creek	California
United States	St. John Macomb Oakland Hospital	Warren	Michigan
United States	Aurora Cancer Care - Milwaukee West	Wauwatosa	Wisconsin
United States	Florida Cancer Specialists East / Sarah Cannon Research Institute	Wellington	Florida
United States	York Hospital Oncology & Infusion Care in Wells	Wells	Maine
United States	West Chester Hospital	West Chester	Ohio
United States	Florida Cancer Specialists East / Sarah Cannon Research Institute	West Palm Beach	Florida
United States	Windham Hospital (WH)	Willimantic	Connecticut
United States	Florida Cancer Specialists North / Sarah Cannon Research Institute	Winter Park	Florida
United States	York Hospital Oncology & Infusion Care in York	York	Maine

Sponsors (11)

Lead Sponsor	Collaborator
American Society of Clinical Oncology	AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Inc., Merck Sharp & Dohme LLC, Pfizer, Seagen Inc., Taiho Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria	Each cohort includes participants with the same tumor type, genomic variant and study drug. For solid tumors, the Response Evaluation Criteria for Solid Tumors (RECIST) criteria will be used, for non-Hodgkin Lymphoma, the Lugano Criteria will be used, and for multiple myeloma, the International Uniform Response Criteria for Multiple Myeloma will be used.	Assessed at 16 weeks of treatment
Secondary	Overall survival (OS)	OS will be estimated using the Kaplan-Meier method	Duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years