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
Phase: Phase 2
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01953926
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-615
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.
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
James Mier, MD,
Beth Israel Deaconess Medical Center
Dejan Juric, MD,
Massachusetts General Hospital
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute:
Andrew Wolanski, 617-632-6623,
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- Histologically confirmed cancers for which no curative therapy exists.
- Documented HER2 mutation.
- Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib,
- Patients who are receiving any other anticancer agents.
- Symptomatic or unstable brain metastases.
- Women who are pregnant or breast-feeding.
Note: There are additional inclusion and exclusion criteria. The study center will
determine if you meet all of the criteria.