Research & Innovation

Head and Neck Clinical Trials

Clinical Trials

Alliance A071701

Genomically-Guided Treatment Trial in Brain Metastases (NCT03994796)

Physician & Study Coordinator

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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Synopsis

This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

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Eligibility Criteria
  • Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

  • Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

  • Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

  • Patients must be able to undergo MRI with contrast

  • Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

  • For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

  • For TNBC, patients must have had at least one chemotherpy in the metastatic setting

  • For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

  • For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

  • For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

  • No known current diffuse leptomeningeal involvement

  • No surgery within 2 weeks prior to or after registration

  • No chemotherapy within 14 days prior to registration

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