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 (TAPUR)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    3581
  • sponsor
    American Society of Clinical Oncology
Updated on 26 May 2022
ct scan
vasectomy
cancer
lymphoma
multiple myeloma
hodgkin's disease
gilbert's syndrome
neutrophil count
advanced cancer
nivolumab
solid tumor

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.

Details
Condition Lymphoma, Non-Hodgkin, Multiple Myeloma, Advanced Solid Tumors
Treatment Cetuximab, Regorafenib, Pembrolizumab, Afatinib, Sunitinib, Erlotinib, olaparib, Temsirolimus, Axitinib, dasatinib, Palbociclib, Vismodegib, bosutinib, Crizotinib, Abemaciclib, Entrectinib, Talazoparib, vemurafenib and cobimetinib, Trastuzumab and Pertuzumab, Nivolumab and Ipilimumab, Larotrectinib, Atezolizumab and PHESGO, Atezolizumab and Talazoparib, Tucatinib plus Trastuzumab Subcutaneous (SC)
Clinical Study IdentifierNCT02693535
SponsorAmerican Society of Clinical Oncology
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

Absolute neutrophil count ≥ 1.5 x 106/µl
Hemoglobin > 9.0 g/dl
Platelets > 75,000/µl
Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome
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)
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 physicial or
radiographic exam or evaluable disease (per RECIST v1.1 for solid tumor
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
Lugano criteria for non Hodgkin lymphoma or International Myeloma Working
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
Group criteria for multiple myeloma), defined as at least one lesion that can
For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome
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
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
with conventional techniques or as ≥10 mm with spiral computed tomography (CT)
scan, Magnetic Resonance Imaging (MRI), or a subcutaneous or superficial
Exclusion Criteria
lesion that can be measured with calipers by clinical exam. For lymph nodes
the short axis must be ≥15 mm. Patients who have assessable disease by
Patients with primary brain tumors or leptomeningeal metastases are excluded
physical or radiographic examination but do not meet these definitions of
measurable disease are eligible and will be considered to have evaluable
disease. Patient's whose disease cannot be objectively measured by physical or
Note: there are additional exclusion criteria that may apply
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
Note: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have
measurable and evaluable disease per RECIST v1.1
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 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
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