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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||February 2016||Phase 2||Interventional|
Primary Outcome 1 - Measure: best overall response (ORR)
Primary Outcome 1 - Time Frame: 2 years
- 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, 5, 6 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. Patients with
HER2 amplification identified by another method or criteria must be approved by the
Principal Investigator and may enroll in the Other" Cohort 4.
- 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, modified PET Response
Criteria in Solid Tumors (PERCIST)). Patients with salivary gland cancers (Cohort 5)
may be eligible on the basis of evaluable disease on modified PET.
- Karnofsky Performance Status 70% or above.
- Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiogram (ECHO) or
multiple gated acquisition scan (MUGA).
- Negative β-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 childbearing 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/µL within 30 days prior to C1D1
- Platelet count ≥ 100,000/µL 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
- 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
- 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 Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Alan Ho, MD, PhD
Role: Principal Investigator
Affiliation: Memorial Sloan Kettering Cancer Center
Name: Alan Ho, MD, PhD
|Memorial Sloan Kettering Cancer Center
New York, New York 10065
Alan Ho, MD, PhD