Rollover Study Of Lapatinib In Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169533
First received: September 9, 2005
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.


Condition Intervention Phase
Neoplasms, Breast
Cancer
Drug: GW572016 oral tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen [ Time Frame: Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival [ Time Frame: Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites. ]

Enrollment: 31
Study Start Date: August 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Lapatinib either 750, 1000, 1250 or 1500 mgs
Drug: GW572016 oral tablets
Lapatinib either at 750, 1000, 1250 or 1500 mgs
Other Name: GW572016 oral tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen.
  • Ability to understand and provide written informed consent to participate in this trial.
  • Is male or female.
  • Female and male subjects agree to the protocol specific birth control measures

Exclusion Criteria:

  • Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
  • Is a pregnant or lactating female.
  • Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
  • Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2).
  • Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  • Has a left ventricular ejection fraction (LVEF) < 40% based on MUGA or ECHO.
  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: NCT00169533

Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Israel
GSK Investigational Site
Tel Aviv, Israel, 64239
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00169533     History of Changes
Other Study ID Numbers: EGF19060
Study First Received: September 9, 2005
Last Updated: April 21, 2011
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
safety
tolerating lapatinib
Lapatinib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014