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Using FDA-approved drugs to target specific tumor gene abnormalities in advanced cancer patients

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Phase 2 Interventional American Society of Clinical Oncology · NCT02693535

This study is testing if certain FDA-approved drugs can help advanced cancer patients with specific gene changes feel better when standard treatments haven't worked.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment4200 (estimated)
Ages12 Years and up
SexAll
SponsorAmerican Society of Clinical Oncology Academic / other
Locations174 sites (Birmingham, Alabama and 173 other locations)
Trial IDNCT02693535 on ClinicalTrials.gov

What this trial studies

The TAPUR study aims to evaluate the safety and effectiveness of FDA-approved targeted therapies in patients with advanced cancers that have actionable genomic variants. This non-randomized trial will collect real-world data on how oncologists prescribe these therapies and the outcomes associated with them. Patients aged 12 and older with specific types of cancers, including lymphoma and multiple myeloma, will be enrolled if they have not responded to standard treatments. The study will also explore the choice of molecular profiling tests used by clinicians to guide treatment decisions.

Who should consider this trial

Good fit: Ideal candidates include patients aged 12 and older with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma who have not benefited from standard treatments.

Not a fit: Patients with early-stage cancers or those who are responding to standard anti-cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with advanced cancers that are tailored to their specific genetic profiles.

How similar studies have performed: Other studies utilizing targeted therapies based on genomic profiling have shown promising results, indicating that this approach is both relevant and potentially effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 173 other locations

+124 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumorscanceroff-labelprecision medicinetargeted therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.