Clinical Trials /

Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

NCT02675829

Description:

The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Trial of <span class="go-doc-concept go-doc-intervention">Ado-Trastuzumab Emtansine</span> for Patients With <span class="go-doc-concept go-doc-biomarker">HER2</span> <span class="go-doc-concept go-doc-keyword">Amplified</span> or <span class="go-doc-concept go-doc-keyword">Mutant</span> Cancers

Title

  • Brief Title: Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
  • Official Title: A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
  • Clinical Trial IDs

    NCT ID: NCT02675829

    ORG ID: 15-335

    Trial Conditions

    Solid Tumor Cancers

    Lung Cancer

    Bladder Cancer

    Urinary Tract Cancers

    Trial Interventions

    Drug Synonyms Arms
    ado-trastuzumab emtansine Lung cancers, HER2 mutant, Lung cancers, HER2 amplified, Bladder and urinary tract cancers, HER2 amplified, Other solid tumor cancers, HER2 amplified

    Trial Purpose

    The purpose of this study is to find out what effects, a drug called ado-trastuzumab
    emtansine has on the patient and their cancer which is thought to be controlled by the
    abnormal HER2 gene.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Lung cancers, HER2 mutant Experimental ado-trastuzumab emtansine
    Lung cancers, HER2 amplified Experimental ado-trastuzumab emtansine
    Bladder and urinary tract cancers, HER2 amplified Experimental ado-trastuzumab emtansine
    Other solid tumor cancers, HER2 amplified Experimental ado-trastuzumab emtansine

    Eligibility Criteria

    Inclusion Criteria:

    - Men and women who are 18 years old.

    - Pathologically confirmed advanced solid tumor cancers

    - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory,
    specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT
    (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or
    another HER2 mutation approved by the Principal Investigator

    - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation
    sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments
    (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH)
    with HER2/CEP17 ratio 2.0 at a CLIA laboratory

    - Measurable or evaluable indicator lesion(s) as defined by RECIST v1.1. Patients
    without RECIST measurable disease will be eligible for enrollment to "Other" cohort
    provided their disease can be evaluated using another accepted response criteria
    (e.g. Gynecologic Cancer InterGroup (GCIG) CA125 Response Criteria, PET Response
    Criteria in Solid Tumors (PERCIST).

    - Karnofsky Performance Status 70% or above.

    - Left ventricular ejection fraction (LVEF) 50% measured by echocardiogram (ECHO) or
    multiple gated acquisition scan (MUGA).

    - Negative -human chorionic gonadotropin (hCG) pregnancy test within 2 weeks before
    enrollment for premenopausal women of reproductive capacity and for women less than
    12 months after menopause. Pregnancy screening will be conducted for women up to the
    age of 50 years per institutional standard.

    - Women of child bearing potential must agree to use of a highly effective method of
    contraception from the time of informed consent until 6 months after the last dose of
    ado-trastuzumab emtansine. Men must agree to use a barrier method of contraception
    while on treatment and for 6 months after the last dose of ado-trastuzumab emtansine.

    - Absolute neutrophil count 1,000/L within 30 days prior to C1D1

    - Platelet count 100,000/L within 30 days prior to C1D1

    - Total bilirubin 1.5 x institutional upper limit of normal (ULN), in case of
    Gilbert's syndrome, 2x ULN within 30 days prior to C1D1

    - Aspartate aminotransferase and/or alanine aminotransferase 3 x ULN ( 5 x ULN if
    liver metastases are present) within 30 days prior to C1D1

    - Provide written, informed consent to participate in the study and follow the study
    procedures

    Exclusion Criteria:

    - Prior therapy resulting in cumulative epirubicin dose 900mg/m2 or cumulative
    doxorubicin dose 500mg/m2 or equivalent dose of another anthracycline.

    - Prior therapy with ado-trastuzumab emtansine (patients who had prior trastuzumab or
    other HER2 targeted agents are eligible).

    - Symptomatic congestive heart failure (New York Heart Association Classification
    II-IV).

    - Myocardial infarction or unstable angina within 6 months of enrollment.

    - Unstable ventricular arrhythmia requiring treatment.

    - Grade 3 or worse peripheral neuropathy as defined by CTCAE v4.1.

    - Women who are pregnant or breast-feeding.

    - Known hypersensitivity to any component of ado-trastuzumab emtansine.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    best overall response (ORR)

    Secondary Outcome Measures

    Trial Keywords

    HER2 mutant

    HER2 amplified

    Ado-Trastuzumab Emtansine

    15-335