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Protocol No. UW17152

Principal Investigator Burkard, Mark

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

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

Objective Neratinib is an experimental drug in this study and is being studied as a potential new treatment for patients with cancers which carry specific mutations in genes of the ERBB family (EGFR, ERBB2, ERBB3, or ERBB4 also referred to as HER1, HER2, HER3, or HER4). These mutations are believed to have a role in the oncogenesis, which is the transformation of a normal cell to a cancer cell. An experimental or investigational drug means it has not been approved by the US Food and Drug Administration (US FDA) for these indications

Treatment Neratinib 240mg (six 40mg tablets) by mouth once a day for 28 days without any break

Key Eligibility
  • Men and women who are greater than or equal to18 years old
  • Must have histologically confirmed cancers in patients with activating ERBB mutations and/or EGFR gene amplification and who are refractory to standard therapy or for which standard or curative therapy does not exist or is not considered sufficient or appropriate by the Investigator
    At the time of screening, a previously documented mutation:
  • ERBB2 mutation in breast, bladder/urinary tract, biliary tract, colorectal, endometrial, cervical, gastroesophageal, lung, ovarian, and any other cancers, or
  • EGFR exon 18 mutation in a lung cancer, or
  • EGFR mutation/amplification in a primary brain tumor (primary brain tumor cohort closed), or
  • ERBB3 mutation in any cancer (ERBB3 mutant solid tumor NOS cohort closed)
  • ERBB4 mutation in any cancer
  • At least one measurable lesion, preferably as defined by Response Evaluation Criteria in Solid Tumors
  • Left ventricular ejection fraction (LVEF)greater than or equal to 50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO)
  • Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Male and Female of child bearing potential must agree and commit to use a barrier method of contraception
    EXCLUSION:
  • Prior treatment with any ERBB2-directed TKI (eg, lapatinib, afatinib, dacomitinib, neratinib) with the exception of patients with lung cancer who may have received afatinib or other pan-HER or EGFR TKIs and remain eligible
  • Received prior therapy resulting in a cumulative epirubicin dose greater than 900 mg/m2 or cumulative doxorubicin dose greater than 450 mg/m2 . If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 450 mg/m2 doxorubicin
  • Symptomatic or unstable brain metastases
  • QTc interval greater than 450 ms for men or greater than 470 ms for women, or known history of congenital QT-prolongation or Torsade de pointes
  • Inadequate bone marrow, renal or hepatic function
  • Active infection
  • Women who are pregnant, are planning on becoming pregnant, or are breast-feeding
  • Significant chronic gastrointestinal disorder with diarrhea as a major symptom
  • Clinically active infection with a hepatitis virus
  • Unable or unwilling to swallow tablets
  • Patients with known activating KRAS mutations
  • Known hypersensitivity to paclitaxel (Taxol) or products containing Cremophor EL
  • Severe dyspnea at rest

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park