Physician

Neil Belman, DO

Study Coordinator

Cynthia Evancho
484-658-2534
Cynthia.Evancho@sluhn.org

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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

Darius Desai MD

Study Coordinator

Vivian Colon
484-658-1793

vivian.colon@sluhn.org

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Synopsis: Comparing the Clinical Impact of Pancreatic Cyst Suveillance Programs

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• Patients must have completed a CT, MRI or EUS within 6 months prior to randomization thatreveals one or more ≥ 1 cm pancreatic cyst(s)
• No prior diagnosis of pancreatic malignancy of any type
• No prior history pancreatic resection
• Patients with pancreatic lesions without malignant risk (pseudo cyst or classic cystic lesions)are not eligible
• No family pancreatic history of pancreatic adenocarcinoma in one or more first degreerelatives
• Patients must have be ≥ 50 years and ≤ 75 years of age

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Synopsis: The study is seeking to determine which of two treatment combinations, gemcitabine and nab-paclitaxel or 5-Fluorouracil, leucovorin, and liposomal irinotecan, is more effective at lengthening the period of time that “vulnerable” patients over the age of 70 with metastatic pancreatic cancer live. There currently is no known best practice for this type of patient, but the commonly used treatment approach is chemotherapy using various agents including those used in this trial.

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

• Newly diagnosed, untreated, biopsy proven metastatic adenocarcinoma of the pancreas
• Must have measurable disease as documented by imaging completed within 4 weeks prior to randomization
• Prior surgery, adjuvant/neoadjuvant chemotherapy and/or radiation therapy is allowed provided therapy was completed at least 6 months prior to randomization
• Patients must be ≥ 70 years of age
• Patients must be deemed "vulnerable" as outlined in the screening geriatric assessment
• Patients must be an English speaker with the ability to understand and completed the informed consent and questionnaires
• ECOG 0-2

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