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

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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

Tracking Information
First Submitted Date  ICMJE February 3, 2016
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date September 8, 2022
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
Official Title  ICMJE A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor Cancers
  • Lung Cancer
  • Bladder Cancer
  • Urinary Tract Cancers
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Cohort 1: Lung cancers, HER2 mutant
    Intervention: Drug: ado-trastuzumab emtansine
  • Experimental: Cohort 2: Lung cancers, HER2 amplified
    Intervention: Drug: ado-trastuzumab emtansine
  • Experimental: Cohort 3: Colorectal cancers
    Intervention: Drug: ado-trastuzumab emtansine
  • Experimental: Cohort 4: Endometrial cancers
    Intervention: Drug: ado-trastuzumab emtansine
  • Experimental: Cohort 5: Salivary gland cancers
    Intervention: Drug: ado-trastuzumab emtansine
  • Experimental: Cohort 6: Other solid cancers
    Intervention: Drug: ado-trastuzumab emtansine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2022)		 140
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)		 72
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bob Li, MD 646-608-3791
Contact: Gopakumar Iyer, MD 646-422-4362
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02675829
Other Study ID Numbers  ICMJE 15-335
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Bob Li, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP