Phase 2 TrialThe TAPUR Study

Targeted Therapies for Advanced Cancer

Exploring FDA-approved drugs based on specific tumor genes. Join a nationwide registry aiming to find new paths forward in precision medicine.

Prioritizing Patient Safety
12+ Years Old Eligibility
Information

About the Study

TAPUR: Testing the Use of FDA Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

Brief 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.

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.

Key Eligibility 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:
    1. Absolute neutrophil count ? 1.5 x 10^6/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. AST/ALT < 2.5 x institutional upper limit of normal (ULN)
    6. Serum creatinine ? 1.5 × ULN
  • Patients must have disease that can be objectively measured by physical or radiographic exam.

Who can join the TAPUR study?

Review the criteria below to see if this study might be a good fit for you.

You may qualify if:

  • You are 12 years of age or older.
  • You have been diagnosed with advanced cancer (solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma).
  • Standard treatments are no longer working for you, or none are available.
  • Your liver, kidneys, and blood counts are functioning at required levels.
  • Your cancer can be objectively measured by physical exam or scans.

You may not qualify if:

  • Your tumor does not have a potentially actionable genomic variant.
  • Your overall performance status is outside the required range (ECOG 0-2).
  • You are currently pregnant or breastfeeding.
  • You do not meet specific organ function requirements for the targeted drug.

Not sure if you qualify?

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Study Benefits

Explore the purpose and potential advantages of participating in the TAPUR Study for advanced stage cancer.

Targeted Therapies

Access to FDA-approved targeted therapies contributed by collaborating pharmaceutical companies.

Genomic Focus

Explore treatment approaches based on your tumor's specific actionable genomic variant.

Advance Research

Help develop hypotheses for additional clinical trials by contributing to this vital registry.

Information

Frequently Asked Questions

Important details regarding participation in the TAPUR Study.

What is a clinical trial and is it safe?

A clinical trial is a research study involving human volunteers to evaluate new medical approaches. The TAPUR Study is a non-randomized trial focused on describing the safety and efficacy of commercially available, FDA-approved targeted anticancer drugs. Patient safety is our highest priority, and you will be closely monitored by medical professionals throughout your participation.

How long will I be in the study?

The length of time you participate in the TAPUR Study depends on how your specific advanced cancer responds to the targeted therapy. You may continue to receive the study treatment as long as you are benefiting from it and not experiencing unacceptable side effects. Your study doctor will discuss the expected timeline based on your individual situation.

What are the possible risks and side effects?

Because the TAPUR Study uses various FDA-approved targeted therapies, the specific risks and side effects depend on the exact medication prescribed for your tumor's genomic variant. Before you join, your doctor will provide a detailed document explaining the known risks associated with the specific drug you will receive.

Will my information be kept confidential?

Yes. Protecting your privacy is a fundamental requirement of this study. All your medical and personal information collected during the trial will be kept strictly confidential in accordance with HIPAA regulations and standard clinical research protocols. Your identity will not be revealed in any reports or publications resulting from the study.

Can I leave the study if I change my mind?

Absolutely. Your participation in the TAPUR Study is entirely voluntary. You have the right to withdraw from the study at any time, for any reason, without any penalty or loss of benefits to which you are otherwise entitled. If you choose to leave, your doctor will discuss alternative treatment options with you.

Will I receive the actual medication or a placebo?

You will receive the actual medication. The TAPUR Study is a non-randomized trial, meaning there is no placebo group. If you meet the eligibility criteria and your tumor harbors a specific genomic variant, you will be prescribed the corresponding targeted anticancer drug contributed by collaborating pharmaceutical companies.

What happens after the study ends?

After your participation concludes, you will continue to receive care from your regular oncologist. Results from the study are posted as they become available for individual cohorts at www.tapur.org/news. Additionally, all overall study results will be made available on clinicaltrials.gov at the end of the study to help inform future cancer treatments.