Principal Investigator
Enrollment Status
Clinical Trial ID
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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Phase
Phase 2
Funding Agency/Sponsor
Externally Peer-Reviewed
Disease
Breast Cancer
Enrollment 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