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The Targeted Agent and Profiling Utilization Registry (TAPUR) Study

October 15, 2019

Research & Trial Information

SCHEMA

Protocol#: TAPUR

Cancer Type: Genomic Based Trial

Patient Eligibility:

  1. Patient (age 12 years*) with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated.

  2. ECOG performance status 0-2.
  3. Patients must have measurable or evaluable disease. Patient’s whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible.
  4. Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression. 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. Note: Eligible genomic tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS), whole exome sequencing (WES). The test may have been performed on a fresh or paraffin-embedded specimen of the primary tumor or a metastatic deposit or on cell free DNA derived from plasma, as determined by the treating physician, and must reveal a potentially actionable genomic variant.

  5. Have a tumor genomic profile for which treatment with one of the FDA approved targeted anti-cancer therapies included in this study has potential clinical benefit based on the criteria.

  6.  For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.

  7.  No ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to antitumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of CTCAE grade 3 will be excluded.

  8. No previous treatment with the selected study drug for the same malignancy.
  9. If the patient’s tumor has a genomic variant known to confer resistance to an anticancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug.

  10.  If the patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ 1 month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific exclusion criteria.
  11. Patients with primary brain tumors are excluded. Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician 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.

  12. Patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.

  13. Patients with left ventricular ejection fraction (LVEF) known to be < 40% are not eligible.

  14.  Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment are not eligible.

  15. Patients with acute gastrointestinal bleeding within 1 month of start of treatment are not eligible.

  16.  Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, severe psychiatric illness situations, or anticipated or planned anti-cancer treatment or surgery.

  17. Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician, are not eligible to receive that drug.

  18.  Patients whose disease is not measurable or assessable by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible.

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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