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An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00207155
Enrollment
110
Registered
2005-09-21
Start date
2003-12-31
Completion date
2006-02-28
Last updated
2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Brief summary

The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer

Interventions

DRUGCetuximab

IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Measurable disease Tumor available for biopsies. Life expectancy of at least 3 months.

Exclusion criteria

* Known or documented brain metastases prior to Cetuximab therapy.

Design outcomes

Primary

MeasureTime frame
Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Secondary

MeasureTime frame
Radiographic Response

Countries

Canada, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026