NCT00104117

Study of XL999 in Adults With Solid Tumors

A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Symphony Evolution, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	XL999	XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2005-02-24
• Last updated: 2010-02-19

Locations

2 sites across 1 country: United States