Study on Ado-Trastuzumab Emtansine for Patients with HER2 Amplified or Mutant Cancers
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT02675829
This clinical trial is exploring the effects of a drug called ado-trastuzumab emtansine on patients with cancers that are influenced by the abnormal HER2 gene.
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Program Overview
The aim of this study is to understand how the drug ado-trastuzumab emtansine affects patients and their cancers, which are believed to be driven by changes in the HER2 gene. This drug is being tested to see if it can help control these types of cancers.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Have advanced solid tumor cancers confirmed by medical tests.
- For certain groups, have specific HER2 mutations in lung cancer confirmed by a certified lab.
- For other groups, have HER2 amplification confirmed by specific genetic tests or other approved methods.
- Have measurable or evaluable cancer lesions as defined by standard criteria.
- Have a performance status of 70% or higher, meaning able to carry out normal activities with some effort.
- Have a heart function of 50% or higher as measured by specific heart tests.
- Women of childbearing age must have a negative pregnancy test before joining the study.
- Agree to use effective birth control during the study and for a period after the last dose.
- Have certain blood cell counts and liver function within specified limits.
- Agree to provide written consent to participate in the study and follow its procedures.
Exclusion Criteria
- Have had certain high doses of specific chemotherapy drugs in the past.
- Have previously been treated with ado-trastuzumab emtansine.
- Have heart failure or recent severe heart problems.
- Have severe nerve damage.
- Are pregnant or breastfeeding.
- Have an allergy to any part of ado-trastuzumab emtansine.
- Have a history of certain lung diseases.
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