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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01513083
First received: January 16, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab emtansine
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal hepatic function Drug: trastuzumab emtansine
Multiple intravenous doses
Experimental: Mild hepatic dysfunction Drug: trastuzumab emtansine
Multiple intravenous doses
Experimental: Moderate hepatic dysfunction Drug: trastuzumab emtansine
Multiple intravenous doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </=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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513083

Contacts
Contact: Reference Study ID Number: BO25499 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Florida
Recruiting
Fort Myers, Florida, United States, 33905
United States, Michigan
Completed
Detroit, Michigan, United States, 48201
United States, Oregon
Completed
Portland, Oregon, United States, 97239
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
Canada, Ontario
Completed
Ottawa, Ontario, Canada, K1H8L6
Completed
Toronto, Ontario, Canada, M5G 2M9
France
Completed
Marseille, France, 13273
Recruiting
Paris, France, 75231
Completed
Toulouse, France, 31059
Italy
Recruiting
Catanzaro, Calabria, Italy, 88100
Completed
Udine, Friuli-Venezia Giulia, Italy, 33100
Spain
Completed
Barcelona, Spain, 08003
Recruiting
Madrid, Spain, 28041
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01513083     History of Changes
Other Study ID Numbers: BO25499, 2011-004591-10
Study First Received: January 16, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Maytansine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014