Targeted Agent and Profiling Utilization Registry Study

April 9, 2020

Clinical Trial Information

Schema Tapur

PROTOCOL: TAPUR

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

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.
  4. Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression.
    1. 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 as defined in Section 5.0, or protein overexpression by IHC.
  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.
  6. 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 (start of study treatment).
  7. Patients with new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of study treatment.
  8. Patients with prior brain radiation will also be eligible provided that there are new or residual, non-irradiated measurable brain lesions. If the lesions are previously radiated, those must demonstrate unequivocal progression of disease in the opinion of the treating physician.
  9. Have completed brain surgery or radiation ≥ 14 days prior to initiating the study treatment and recovered from all acute effects and not anticipated to require urgent brain surgery or radiation for symptomatic progression as assessed by the treating physician.

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Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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