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: 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
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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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.
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 physicial or
 radiographic exam or evaluable disease (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 computed tomography (CT) scan, Magnetic Resonance Imaging (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. Patients who have assessable
 disease by 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 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