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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)

Igor Puzanov


  • 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) following treatment with neratinib in patients with solid tumors that test positive for somatic human epidermal growth factor receptor mutations in the ERBB gene family (EGFR, HER2, and/or HER3) or EGFR gene amplification.
  • Disease Sites: Urologic; Neuro-Oncology; Bladder; Ovarian; Esophageal; Colon; Uterine; Gastric/Gastroesophageal
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Neratinib (HKI-272)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01953926
  • Secondary Protocol No: PUMA-NER-5201


None Provided.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


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.