NCT00044343|CompletedPhase 2

GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

EGF20004

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredAug 2002

StartedSep 2002

CompletionOct 2003

Brief Summary

The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline

Completed

Started Sep 2002

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach

2 countries

57 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

August 26, 2002

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2002

Completed

4 days until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed

Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

August 26, 2002

Last Update Submit

July 9, 2014

Conditions

Colorectal Cancer

Keywords

colorectal cancerEGFR inhibitorlapatinibmetastatic

Outcome Measures

Primary Outcomes (1)

Tumor response rate (complete or partial).
6 Months

Secondary Outcomes (1)

Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers
6 Month

Interventions

lapatinibDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provide signed informed consent.
Refractory Stage IV metastatic colorectal cancer.
Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
No more than one prior therapy.
Tumor tissue available for testing.
weeks since first-line cancer regimen.
Able to swallow and retain oral medication.
Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
Adequate kidney and liver function.
Adequate bone marrow function.

You may not qualify if:

Pregnant or lactating female.
Conditions that would affect absorption of an oral drug
First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
Severe cardiovascular disease or cardiac (heart) disease requiring a device.
Active infection.
Brain metastases.
Concurrent cancer therapy or investigational therapy.
Use of oral or intravenous steroids.
Unresolved or unstable, serious toxicity from prior therapy.
Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.

Contact the study team to confirm eligibility.