A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01513083
• Date of registration: 16/01/2012
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
• Scientific title: A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
• Date of first enrolment: February 2012
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01513083
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada, France, Italy, Spain, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically or cytologically documented invasive metastatic breast cancer

- Human epidermal growth factor receptor 2 (HER2) -positive disease

- Adequate bone marrow and organ function (other than hepatic dysfunction allowed by
protocol)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Left ventricular ejection fraction >/=50%

- Normal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A
or B)

Exclusion Criteria:

- History of Grade >/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in
response to trastuzumab

- Investigational therapy or any other anticancer therapy treatment

- Previous treatment with trastuzumab emtansine

- Brain metastases that are untreated or symptomatic or require therapy to control
symptoms or any radiation, surgery or other therapy to control symptoms from brain
metastases within 1 month of the first study treatment

- History of other malignancy within the last 5 years, except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer,
or other cancers with a similar outcome as those mentioned above

- Current peripheral neuropathy of Grade >/=2

- Child-Pugh Class C hepatic impairment

- Encephalopathy >/= Grade 2

- For patients with normal hepatic function: history of drug or alcohol addiction or
history of hepatitis B and/or hepatitis C

- Active hepatitis A, B and/or C

- Current unstable ventricular arrhythmia requiring treatment

- History of symptomatic CHF (NYHA Classes II-IV)

- History of myocardial infarction or unstable angina within 6 months of enrollment

- History of a decrease in LVEF to<40% or symptomatic CHF with previous trastuzumab
treatment

- Pregnant or lactating women

- Known HIV infection



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: trastuzumab emtansine

Primary Outcome(s)

Pharmacokinetics: Area under the concentration-time curve [Time Frame: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3]

Secondary Outcome(s)

Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function [Time Frame: approximately 2 years]

Secondary ID(s)

2011-004591-10

BO25499

Source(s) of Monetary Support

Please refer to primary and secondary sponsors