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Rollover Study Of Lapatinib In Cancer Patients

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms, Breast; Cancer

Intervention: GW572016 oral tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen

Secondary outcome: Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Tel Aviv 64239, Israel

GSK Investigational Site, Edmonton, Alberta T6G 1Z2, Canada

GSK Investigational Site, Indianapolis, Indiana 46202, United States

GSK Investigational Site, Lebanon, New Hampshire 03756, United States

GSK Investigational Site, Albuquerque, New Mexico 87131, United States

GSK Investigational Site, Chapel Hill, North Carolina 27599, United States

GSK Investigational Site, Durham, North Carolina 27705, United States

GSK Investigational Site, Cleveland, Ohio 44106, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19111, United States

GSK Investigational Site, Nashville, Tennessee 37203, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

Additional Information

Starting date: August 2004
Last updated: April 21, 2011

Page last updated: August 23, 2015

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