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NCT00778167 · ClinicalTrials.gov registry record · Phase 1

Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

A Phase 1 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
2
Study locations

NCT00778167 is a Phase 1 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 689-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00778167, a Phase 1 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
2
Study locations

Study Summary

This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether erlotinib hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG erlotinib hydrochloride
  • BIOLOGICAL cixutumumab

Study Locations (2)

Colorado

  • University of Colorado - Denver

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2008-10
Est. Completion 2012-05
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00778167

The ClinicalTrials.gov registry entry for NCT00778167 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 689-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (97% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Stage IV Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT00778167 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, New York.

Frequently Asked Questions

What is clinical trial NCT00778167 about?

NCT00778167 is a clinical study titled "Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer". This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop th...

What is the current status of trial NCT00778167?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-10. Estimated completion is 2012-05.

What conditions does trial NCT00778167 study?

This clinical trial studies the following conditions: Stage IV Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT00778167?

The interventions under investigation include: laboratory biomarker analysis (OTHER), erlotinib hydrochloride (DRUG), cixutumumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00778167?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00778167 being conducted?

This trial has 2 study locations across Colorado, New York. 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 Editorial

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.