Last updated on October 2018

Study of the Pan-ERBB Inhibitor Neratinib Given in Combination With Everolimus Palbociclib or Trametinib in Advanced Cancer Subjects With EGFR Mutation/Amplification HER2 Mutation/Amplification HER3/4 Mutation or KRAS Mutation


Brief description of study

Objectives

Primary Objectives:

To evaluate the safety and tolerability of neratinib when combined with one of the following

agents

Arm 1: Everolimus (mTOR inhibitor) Arm 2: Palbociclib (CDK 4/6 inhibitor) Arm 3: Trametinib (MEK inhibitor) To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of neratinib combination therapy.

Secondary Objectives:

To determine preliminary anti-tumor efficacy of neratinib combination therapy. To determine pharmacodynamic markers in tissue, blood and plasma that may predict outcome.

To explore the potential of drug-drug interactions by evaluating the pharmacokinetic profile of each agent when administered in these combinations: neratinib+everolimus, neratinib+palbociclib, and neratinib+trametinib and blood-based biomarkers.

Clinical Study Identifier: NCT03065387

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Recruitment Status: Open


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