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

NCT00078455 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-03-05

No results posted yet for this 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.

Conditions

  • Non-Small-Cell Lung Carcinoma

Interventions

DRUG

ILX651

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Completion
2005-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00078455 on ClinicalTrials.gov