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Completed Phase 2 Interventional

Study of ILX651 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

ClinicalTrials.gov ID: NCT00078455

Public ClinicalTrials.gov record NCT00078455. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 7:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile.

Study identification

NCT ID
NCT00078455
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2003
Primary completion
Not listed
Completion
Jul 31, 2005
Last update posted
Mar 4, 2015

2003 – 2005

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
US Oncology/ Arizona Clinical Research Center Tucson Arizona 85712
Cancer Institute Medical Group Santa Monica California 90404
Anshutz Cancer Pavillion Aurora Colorado 80010
US Oncology / Ocala Oncology Ocala Florida 34474
US Oncology / Central Indiana Cancer Centers Indianapolis Indiana 46227
Hematology and Oncology Specialists New Orleans Louisiana 70115
Sarah Cannon Cancer Center Nashville Tennessee 37203
US Oncology / Texas Cancer Center Dallas Texas 75230
Joe Arrington Cancer Center Lubbock Texas 79410
US Oncology / Tyler Cancer Center Tyler Texas 75702

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00078455, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 4, 2015 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00078455 live on ClinicalTrials.gov.

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