NCT00491699

Safety Study of XL999 in Adults With Non-Small-Cell Lung Cancer

A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Symphony Evolution, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safest dose of XL999 and how well subjects with Non-Small-Cell Lung Cancer tolerate XL999. XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	XL999	XL999 will be administered as a once-weekly 4 hour IV infusion as a single agent. The first cohort will be dosed at 0.4 mg/kg IV once weekly. The maximum dose cohort will not exceed 1.6 mg/kg IV once weekly. Ten subjects are planned for each dosing cohort, with dose escalation dependent on safety and available PK data from prior cohorts

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-01-01
• Completion: 2008-05-01
• First posted: 2007-06-26
• Last updated: 2010-02-19

Locations

5 sites across 1 country: United States