This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02675829
First received: February 3, 2016
Last updated: August 9, 2017
Last verified: August 2017
  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.

Condition Intervention Phase
Solid Tumor Cancers Lung Cancer Bladder Cancer Urinary Tract Cancers Drug: ado-trastuzumab emtansine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • best overall response (ORR) [ Time Frame: 2 years ]
    As soon as evaluations for each tumor assessment are completed, the Investigator should assess the patient's overall response (target plus non- target lesions) based on criteria and overall response algorithms as defined in RECIST version 1.1. Scans must be assessable for all evaluations.


Estimated Enrollment: 100
Actual Study Start Date: February 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung cancers, HER2 mutant Drug: ado-trastuzumab emtansine
Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Experimental: Lung cancers, HER2 amplified Drug: ado-trastuzumab emtansine
Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Experimental: Bladder and urinary tract cancers, HER2 amplified Drug: ado-trastuzumab emtansine
Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
Experimental: Other solid tumor cancers, HER2 amplified Drug: ado-trastuzumab emtansine
Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02675829

Contacts
Contact: Bob Li, MD 646-888-4201
Contact: Gopakumar Iyer, MD 646-422-4362

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Bob Li, MD    646-888-4201      
Contact: Gopakumar Iyer, MD    646-422-4362      
Principal Investigator: Bob Li, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Bob Li, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02675829     History of Changes
Other Study ID Numbers: 15-335
Study First Received: February 3, 2016
Last Updated: August 9, 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
HER2 mutant
HER2 amplified
Ado-Trastuzumab Emtansine
15-335

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Ado-trastuzumab emtansine
Trastuzumab
Maytansine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017