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
Purpose
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. ********************************************************************
Conditions
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Advanced Solid Tumors
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Group 4 (CDKN2A, CDK4, CDK6) |
Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation |
|
|
Other Group 5 (CSF1R,PDGFR,VEGFR) |
Participants receive sunitinib - dosage, frequency and duration per label; acceptable genomic matches include CSF1R, PDGFR, VEGFR1/2/3, KIT, FLT-3, RET, FGFR1/2/3, VHL amplifications or mutations |
|
|
Other Group 6 (mTOR, TSC) |
Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations |
|
|
Other Group 8 (ERBB2) |
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations |
|
|
Other Group 9 (BRAF V600E/D/K/R) |
Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations |
|
|
Other Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF) |
Participants receive regorafenib - dosage, frequency and duration per label; acceptable genomic matches include RET, VEGFR1/2/3, KIT, PDGFRβ, RAF-1, BRAF mutations or amplifications |
|
|
Other Group 14 (BRCA1/2; ATM) |
Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions |
|
|
Other Group 16 (MSI-H, high mutational load and others) |
Participants receive nivolumab and ipilimumab - dosage, frequency and duration per label; acceptable genomic matches include MSI high status, high tumor mutational burden, MLH1, MSH2/6, PMS2, EPCAM mutations, specific POLE or POLD1 mutations, BRCA1/2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1/2/3/4/5, PCNA, RPA1/2/3/4, and SSBP1 loss of function mutations |
|
|
Other Group 17 (CDKN2A, CDK4, CDK6) |
Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications, CDKN2B loss or mutation |
|
|
Other Group 19 (BRCA1/2, PALB2) |
Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations |
|
|
Other Group 21 (BRCA1/2, PALB2, ATM, and others) |
Participants receive atezolizumab plus talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic mutations in BRCA1/2, PALB2, ATM, ATR, CHEK2, FANCA, RAD51C, NBN, MLH1, MRE11A, CDK12; positive genomic instability score reported on the Myriad MyChoice CDx test; or Genomic Loss of Heterozygosity (LOH) Score above threshold as reported on a FoundationOne CDx test or another qualifying test for TAPUR with MTB approval |
|
|
Other Group 24 (ERBB2) |
Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations |
|
|
Other Group 25 |
Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation |
|
|
Other Group 26 (BRAF V600 E mutation ) |
Participants receive Dabrafenib plus Trametinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600 E mutation . |
|
|
Other Group 27 (ERBB2 amplification, ERBB2 (HER2) IHC2+ or IHC3+ overexpression) |
Participants receive Fam-trastuzumab deruxtecan-nxki (ENHERTU®) - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification, For NSCLC Only-ERBB2 (HER2) IHC2+ or IHC3+ overexpression without ERBB2 amplification) |
|
Recruiting Locations
Birmingham, Alabama 35294
Phoenix, Arizona 85338
Auburn, California 95602
Berkeley, California 94705
Los Angeles, California 90025
Oakland, California 94611
Palo Alto, California 94301
Roseville, California 95661
Roseville, California 95661
Sacramento, California 95814
San Francisco, California 94080
San Francisco, California 94115
San Francisco, California 94115
San Francisco, California 94115
San Jose, California 95119
San Leandro, California 94577
Santa Barbara, California 93105
Santa Clara, California 95051
Santa Cruz, California 95065
Santa Cruz, California 994538
Sunnyvale, California 94086
Vallejo, California 94589
Walnut Creek, California 94596
Bridgeport, Connecticut 06606
Hartford, Connecticut 06102
Meriden, Connecticut 06451
New Britain, Connecticut 06053
Norwich, Connecticut 06360
Torrington, Connecticut 06790
Willimantic, Connecticut 06226
Aventura, Florida 33180
Coral Gables, Florida 33146
Deerfield Beach, Florida 33442
Fort Lauderdale, Florida 33308
Gainesville, Florida 32610
Miami, Florida 33136
Miami, Florida 33136
Miami, Florida 33136
Miami, Florida 33176
Miami, Florida 33181
Plantation, Florida 33324
Atlanta, Georgia 30265
Atlanta, Georgia 30322
Savannah, Georgia 31405
Savannah, Georgia 31405
Savannah, Georgia 31405
Savannah, Georgia 31405
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Honolulu, Hawaii 96817
‘Ewa Beach, Hawaii 96706
Chicago, Illinois 60099
Indianapolis, Indiana 46250
Augusta, Maine 04330
Augusta, Maine 04330
Belfast, Maine 04915
Biddeford, Maine 04005
Brewer, Maine 04412
Brewer, Maine 04412
Brunswick, Maine 04011
Kennebunk, Maine 04043
Kittery, Maine 03904
Norway, Maine 04268
Rockport, Maine 04856
Sanford, Maine 04073
Scarborough, Maine 04074
Scarborough, Maine 04074
Scarborough, Maine 04074
South Portland, Maine 04106
Topsham, Maine 04086
Wells, Maine 04090
York Village, Maine 03909
Ann Arbor, Michigan 48106
Detroit, Michigan 48236
Flint, Michigan 48503
Grand Rapids, Michigan 49503
Lansing, Michigan 48912
Livonia, Michigan 48154
Pontiac, Michigan 48341
Saginaw, Michigan 48601
Traverse City, Michigan 48341
Warren, Michigan 48093
Omaha, Nebraska 68198
Concord, New Hampshire 03103
Manchester, New Hampshire 03103
Portsmouth, New Hampshire 03801
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87110
Albuquerque, New Mexico 87131
Las Cruces, New Mexico 88011
Rio Rancho, New Mexico 87124
Lake Success, New York 11042
Mount Kisco, New York 10549
New Hyde Park, New York 11040
New York, New York 10065
New York, New York 10305
Rego Park, New York 11374
Sleepy Hollow, New York 10591
Chapel Hill, North Carolina 27599
Charlotte, North Carolina 28277
Bismarck, North Dakota 58501
Fargo, North Dakota 58122
Cincinnati, Ohio 45219
Kettering, Ohio 45429
West Chester, Ohio 45069
Portland, Oregon 97213
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
East Stroudsburg, Pennsylvania 18301
Hazleton, Pennsylvania 18201
Philadelphia, Pennsylvania 19111
Bluffton, South Carolina 29910
Bluffton, South Carolina 29910
Bluffton, South Carolina 29910
Hilton Head Island, South Carolina 29926
Sioux Falls, South Dakota 57104
Nashville, Tennessee 37203
Houston, Texas 77030
Cedar City, Utah 84720
Salt Lake City, Utah 84107
St. George, Utah 84770
Fairfax, Virginia 22042
Bonney Lake, Washington 98391
Federal Way, Washington 98003
Gig Harbor, Washington 98332
Olympia, Washington 98502
Puyallup, Washington 98373
Seattle, Washington 98104
Tacoma, Washington 98405
Burlington, Wisconsin 53105
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54311
Kenosha, Wisconsin 53142
Marinette, Wisconsin 54143
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53223
Milwaukee, Wisconsin 53227
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53406
Sheboygan, Wisconsin 53081
Summit, Wisconsin 53066
Two Rivers, Wisconsin 54241
Wauwatosa, Wisconsin 53226
More Details
- Status
- Recruiting
- Sponsor
- American Society of Clinical Oncology
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.