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NCT00078455 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Non-Small-Cell Lung Carcinoma, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
10
Study locations

NCT00078455: Completed Phase 2 study of Non-Small-Cell Lung Carcinoma, sponsored by Genzyme, a Sanofi Company.

NCT00078455 is a Phase 2 study of Non-Small-Cell Lung Carcinoma that has completed, run by Genzyme, a Sanofi Company. The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00078455, a Phase 2 study of Non-Small-Cell Lung Carcinoma, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
10
Study locations

Study Summary

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.

Interventions

  • DRUG ILX651

Study Locations (10)

Texas

  • US Oncology / Texas Cancer Center - Dallas
  • Joe Arrington Cancer Center - Lubbock
  • US Oncology / Tyler Cancer Center - Tyler

Arizona

  • US Oncology/ Arizona Clinical Research Center - Tucson

California

  • Cancer Institute Medical Group - Santa Monica

Colorado

  • Anshutz Cancer Pavillion - Aurora

Florida

  • US Oncology / Ocala Oncology - Ocala

Indiana

  • US Oncology / Central Indiana Cancer Centers - Indianapolis

Louisiana

  • Hematology and Oncology Specialists - New Orleans

Tennessee

  • Sarah Cannon Cancer Center - Nashville

Trial Details

FieldValue
Start Date 2003-12
Est. Completion 2005-08
Phase Phase 2
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00078455 record still lists

NCT00078455 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which ILX651 is the first listed.

NCT00078455 lists 10 locations in 8 states (Texas, Arizona, California).

Frequently Asked Questions

What is clinical trial NCT00078455 about?

NCT00078455 is a clinical study titled "Study of ILX651 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma". 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 int...

What is the current status of trial NCT00078455?

This trial is currently completed. It is a Phase 2 study. The study started on 2003-12. Estimated completion is 2005-08.

What conditions does trial NCT00078455 study?

This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma.

What interventions are being tested in trial NCT00078455?

The interventions under investigation include: ILX651 (DRUG).

Who is sponsoring clinical trial NCT00078455?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00078455 being conducted?

This trial has 10 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00078455, the US trial registry maintained by the National Library of Medicine. NCT00078455 (unsized enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.