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

NCT00491699 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2010-02-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Symphony Evolution, Inc.

    lead INDUSTRY

Principal Investigators

  • Lynne A. Bui, MD · Exelixis

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
2007-08-31
Primary Completion
2008-01-31
Completion
2008-05-31

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 NCT00491699 on ClinicalTrials.gov