A Phase II Study of Neratinib in Patients with Solid Tumors Containing Mutated HER2

Full Title

An Open-Label, Phase 2 Study Of Neratinib In Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR,HER2,HER3) Mutations Or EGFR Gene Amplification

Purpose

HER2 is a protein which, when abnormal (mutated), can fuel cancer growth. Neratinib is an investigational drug that blocks some of the functions of the HER2 protein. In this study, researchers are evaluating the safety and effectiveness of neratinib in patients with solid tumors that contain mutated HER2 and for which no standard cure exists. Neratinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HER2 mutation-positive solid tumors that cannot be cured using standard therapies. These include (but are not limited to) bladder, colorectal, endometrial, gastric/esophageal, and ovarian cancers.
  • At least 2 weeks must have passed since completion of prior therapies and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. David Solit at 646-422-4459 or Dr. David Hyman at 646-888-4544.

Protocol

13-140

Phase

II

Investigator

Locations