Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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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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• 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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Physician

Ashley Graul, MD

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Blood and Tissue Procurement Protocol for Product Development and Research.

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• Patients must agree to collection of blood and/or tumor tissue/fluid that is obtained during a standard of care procedure or visit (as of 5/11/23 - no blood collection is necessary unless specifically requested by sponsor)
• For Ovarian cancer - fresh tissue collection of frontline, newly diagnosed, treatment naive, Stage IIIb or IV or first recurrenct, platinum-sensitive tumors (tissue collection must occur prior to initiation of any systemic therapy for recurrence)
• For Ovarian cancer - fluid collection from first tap of ascited or pleural fluid of first recurrence, platinum-sensitive tumors (can be collected prior to or after systemic therapy for recurrence is initiated)

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Physician

Ashley Graul, MD

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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This study is being done to help determine if the use of a hormonal therapy drug, Letrozole, used either by itself or in combination with chemotherapy, will lower the chance of ovarian or peritoneal cancer growing or spreading. The use of Letrozole without chemotherapy may shrink or stabilize the cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is an aromatase inhibitor, which indirectly stops the body from producing estrogen.

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Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

• Newly diagnosed stage II-IV low-grade serous ovarian cancer that shows a nonaberrant pattern p53 by immunohistochemistry
• Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal or suboptimal residual disease status
• Patients must be within ≤8 weeks of primary cytoreductive surgery at the time of study randomization
• Patients must be able to take oral pills
• Patients may not have had prior neoadjuvant or adjuvant chemotherapy or radiotherapy for treatment of this disease
• Patients may not have received prior hormonal therapy for treatment of this disease

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