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NCT01184482 · ClinicalTrials.gov registry record · Phase 1

Lapatinib and Cetuximab in Patients With Solid Tumors

A Phase 1 study of Lung Cancer and Colorectal Cancer, sponsored by Georgetown University.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
1
Study location

NCT01184482 is a Phase 1 study of Lung Cancer and Colorectal Cancer that has completed, run by Georgetown University. The registered enrollment target is 22 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01184482, a Phase 1 study of Lung Cancer and Colorectal Cancer, has completed, sponsored by Georgetown University.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy. Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this receptor from the outside of cancer cells. It is thought that cancer cells can turn this signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been found that combining drugs that target both EGFR and ErbB2 might work better in turning this signal back off. The purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time. In addition, in order to be on this trial, patients must agree to have a tumor biopsy before starting treatment on this study and 21 days after starting treatment. These biopsies are a required part of the study. Patients must also agree to have blood drawn for research testing to see whether genetic differences between patients explain different reactions to and side effects from, these medicines.

Conditions Studied

Lung Cancer Colorectal Cancer Head and Neck Cancer

Interventions

  • DRUG cetuximab and lapatinib

Study Locations (1)

District of Columbia

  • Georgetown University Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2010-06
Est. Completion 2013-09
Phase Phase 1

Sponsor

Georgetown University

227 total trials

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What the Registry Record Tells You About NCT01184482

The ClinicalTrials.gov registry entry for NCT01184482 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which cetuximab and lapatinib is the first listed.

NCT01184482 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT01184482 about?

NCT01184482 is a clinical study titled "Lapatinib and Cetuximab in Patients With Solid Tumors". This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy. Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling ...

What is the current status of trial NCT01184482?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2010-06. Estimated completion is 2013-09.

What conditions does trial NCT01184482 study?

This clinical trial studies the following conditions: Lung Cancer, Colorectal Cancer, Head and Neck Cancer.

What interventions are being tested in trial NCT01184482?

The interventions under investigation include: cetuximab and lapatinib (DRUG).

Who is sponsoring clinical trial NCT01184482?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01184482 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.