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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675829
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : September 8, 2022
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: 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: Cohort 2: 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: Cohort 3: Colorectal cancers 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: Cohort 4: Endometrial cancers 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: Cohort 5: Salivary gland cancers 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: Cohort 6: Other solid cancers 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 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. Effective contraception is required during treatment and for 7 months following the last dose for female participants of reproductive potential and during treatment and for 4 months following the last dose for male participants with female sexual partners of reproductive potential. Male participants should also refrain from donating sperm during treatment and for 4 months following the last dose.
  • 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.
  • History of interstitial lung disease or pneumonitis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675829


Contacts
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Contact: Bob Li, MD 646-608-3791
Contact: Gopakumar Iyer, MD 646-422-4362

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Bob Li, MD    646-608-3791      
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Bob Li, MD    646-608-3791      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Bob Li, MD    646-608-3791      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Bob Li, MD    646-608-3791      
Memorial Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Bob Li, MD    646-608-3791      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Bob Li, MD    646-608-3791      
Contact: Gopakumar Iyer, MD    646-422-4362      
Principal Investigator: Bob Li, MD         
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Bob Li, MD    646-608-3791      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Genentech, Inc.
Investigators
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Principal Investigator: Bob Li, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02675829    
Other Study ID Numbers: 15-335
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
HER2 mutant
HER2 amplified
Ado-Trastuzumab Emtansine
15-335
Additional relevant MeSH terms:
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Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urologic Diseases
Male Urogenital Diseases
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunotoxins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs