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

Status: Recruiting
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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
James Mier, MD, Beth Israel Deaconess Medical Center
Dejan Juric, MD, Massachusetts General Hospital

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed cancers for which no curative therapy exists. - Documented HER2 mutation. Exclusion Criteria: - Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib). - 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.
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