Last updated on June 2017

PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers


Brief description of study

Protocol PEN-221-001 is an open-label, multicenter Phase 1/2a study evaluating PEN-221 in patients with SSTR2 expressing advanced gastroenteropancreatic (GEP) or lung or thymus or other neuroendocrine tumors or small cell lung cancer or large cell neuroendocrine carcinoma of the lung.

Detailed Study Description

Protocol PEN-221-001 will first enroll patients into a dose escalation phase, where a Bayesian logistic regression model, guided by the escalation with overdose control principle and overseen by a safety review committee, will be used to make dose recommendations and estimate the maximum tolerated dose (MTD). Once the MTD has been determined, additional patients will be enrolled into an early expansion phase to confirm or adjust the MTD. Once the MTD has been confirmed, remaining patients will be enrolled into a full expansion phase to assess PEN-221 efficacy.

Clinical Study Identifier: NCT02936323

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Tarveda Clinical Information Center

Massachusetts General Hospital
Boston, MA United States
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Tarveda Clinical Information Center

Beth Israel Deaconess Medical Center
Boston, MA United States
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Tarveda Clinical Information Center

Dana-Farber Cancer Institute
Boston, MA United States
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Tarveda Clinical Information Center

Columbia University Medical Center/ NY Presbyterian
Manhattan, NY United States
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Tarveda Clinical Information Center

Sarah Cannon Research Institute/Tennessee Oncology
Nashville, TN United States
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Tarveda Clinical Information Center

MD Anderson Cancer Center
Houston, TX United States
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Tarveda Clinical Information Center

University College London
London, United Kingdom
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Tarveda Clinical Information Center

The Christie NHS Trust
Manchester, United Kingdom
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