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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics: Area under the concentration-time curve

Outcome Time Frame:

Multiple sampling pre- and up to 21 days post-dose Cycles 1-3

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO25499

NCT ID:

NCT01513083

Start Date:

February 2012

Completion Date:

March 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Miami, Florida  33176
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Eugene, Oregon