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BRIEF TITLE: A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers


  • Org Study ID: 15-335
  • Secondary ID:
  • NCT ID: NCT02675829
  • NCT Alias:
  • Sponsor: Memorial Sloan Kettering Cancer Center - Other
  • Source: Memorial Sloan Kettering Cancer Center

Brief Summary

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 Outcomes:

Primary Outcome 1 - Measure: best overall response (ORR)

Primary Outcome 1 - Time Frame: 2 years

Condition:

  • Solid Tumor Cancers
  • Lung Cancer
  • Bladder Cancer
  • Urinary Tract Cancers

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. 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, 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 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 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/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
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Bob Li, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Bob Li, MD

Phone: 646-888-4201

Email:

Link: Memorial Sloan Kettering Cancer Center

Location

Facility Status Contact
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Bob Li, MD
646-888-4201