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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513083
• Other study ID #: BO25499
• Secondary ID: 2011-004591-10
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2012
• Last updated: November 1, 2016
• Start date: February 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 </=28 days before first study 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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• trastuzumab emtansine
Multiple intravenous doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration-time curve		Multiple sampling pre- and up to 21 days post-dose Cycles 1-3	No
Secondary	Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function		approximately 2 years	Yes