Last updated on August 2019

Neratinib HER Mutation Basket Study (SUMMIT)


Brief description of study

This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

Detailed Study Description

This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti-cancer therapy.

Clinical Study Identifier: NCT01953926

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University of Southern California

Los Angeles, CA United States
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Mayo Clinic Arizona

Phoenix, AZ United States
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City of Hope

Duarte, CA United States
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Stanford Cancer Center

Palo Alto, CA United States
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Mayo Clinic Florida

Jacksonville, FL United States
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University of Miami

Miami, FL United States
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Northwestern University

Chicago, IL United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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University of Michigan

Ann Arbor, MI United States
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Mayo Clinic

Rochester, MN United States
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MMCORC Health Partners

Saint Louis Park, MN United States
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Washington University

Saint Louis, MO United States
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Kettering Medical Center

Kettering, OH United States
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The West Clinic

Germantown, TN United States
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MD Anderson Cancer Center

Houston, TX United States
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Gundersen

La Crosse, WI United States
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UZ Leuven

Leuven, Belgium
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Royal Free Hospital

London, United Kingdom
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