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Rollover Study Of Lapatinib In Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169533
First Posted: September 15, 2005
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: GW572016 oral tablets Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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. ]

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
Actual Study Start Date: August 19, 2004
Study Completion Date: May 5, 2009
Primary Completion Date: May 5, 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169533


Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169533     History of Changes
Other Study ID Numbers: EGF19060
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
safety
tolerating lapatinib
Lapatinib

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