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

NCT01513083 | Completed Phase 1

• 2 other identifiers: BO254992011-004591-10
• Study Type: interventional
• Target: 28
• Locations: 5 countries
• Sites: 13

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics: Area under the concentration-time curve

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

Secondary Outcomes (1)

• Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function

  approximately 2 years

Study Arms (3)

Mild hepatic dysfunction

EXPERIMENTAL

Drug: trastuzumab emtansine

Moderate hepatic dysfunction

EXPERIMENTAL

Drug: trastuzumab emtansine

Normal hepatic function

EXPERIMENTAL

Drug: trastuzumab emtansine

Interventions

trastuzumab emtansine DRUG

Multiple intravenous doses

Mild hepatic dysfunction; Moderate hepatic dysfunction; Normal hepatic function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (13)

Unknown Facility

Fort Myers, Florida, 33905, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Ottawa, Ontario, K1H8L6, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

Marseille, 13273, France

Location

Unknown Facility

Paris, 75231, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Catanzaro, Calabria, 88100, Italy

Location

Unknown Facility

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Unknown Facility

Barcelona, Barcelona, 08003, Spain

Location

Unknown Facility

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (3); IT (2); ES (2); CA (2); US (4)