drugset
drugset / Trial / NCT00078455

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

NCT00078455 ↗

Phase 2 Completed Genzyme, a Sanofi Company
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2003-12
Primary completion
—
Completion
2005-08

Drugs

EvaluationDrugModalityDoseRoute
Subject TASIDOTIN Protein / enzyme biologic — Intravenous

Indications

non-small cell lung carcinoma