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Clinical Trial VICCMD1403


An Open Label, Phase II Study of Neratinib in Patients with Solid Tumors with Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

Principal Investigator(s)

Ingrid Mayer


  • Protocol No. VICCMD1403
  • Open Date: 06/02/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective of this study is to determine the objective response rate at 8 weeks (ORR8) for all cohorts
  • Disease Sites: Urologic; Neuro-Oncology; Bladder; Ovarian; Esophageal; Colon; Uterine; Gastric/Gastroesophageal
  • Therapies: Chemotherapy - cytotoxic; Hormonal Therapy; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Fulvestrant; Neratinib (HKI-272); Paclitaxel
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01953926
  • Secondary Protocol No: PUMA-NER-5201


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