Rollover Study Of Lapatinib In Cancer Patients | NCT00169533

Studies
Rollover Study Of Lapatinib In Cancer Patients

NCT00169533

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

31Actual

Phase

Phase 1

Conditions

Neoplasms, Breast

Interventions

GW572016 oral tablets

Countries

United States
Canada
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2004Actual

Primary Completion Date

May 5, 2009Actual

Completion Date

May 5, 2009Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2017

Last Update Posted Date

Nov 17, 2017Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Lapatinib either 750, 1000, 1250 or 1500 mgs	Drug: GW572016 oral tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GW572016 oral tablets	Drug	Lapatinib either at 750, 1000, 1250 or 1500 mgs	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen		Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

Secondary Outcomes

Measure	Description	Time Frame
Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival		Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Indianapolis	Indiana	46202	United States
GSK Investigational Site

Label	URL
Results for study EGF19060 can be found on the GSK Clinical Study Register.	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077341	Lapatinib

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided