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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: XL999

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Univserzity Hospitals of Cleveland
  • Texas
    • San Antonio, Texas, United States, 78229
      • Cancer Therapy and Research Center, Institute for Drug Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced solid tumor
• Cancer that has progressed on currently available therapies
• Life expectancy of >3 months
• Adequate bone marrow, liver, and kidney function
• Willing to use accepted method of contraception during the course of the study
• Negative pregnancy test (females)
• Written informed consent

Exclusion Criteria:

• Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
• Radiotherapy within 4 weeks of the start of treatment
• Subjects with known brain metastasis
• Uncontrolled medical disorder such as infection or cardiovascular disease
• Subjects known to be HIV positive
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors	Inclusion until 30 days post last treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors	Various timepoints from pre-dosing until 48 hours post dose.
To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.	At various timepoints from pre-dosing until 48 hours post dosing

Collaborators and Investigators

• Sponsor: Symphony Evolution, Inc.
• Investigators: Study Director: Paul Woodard, MD, Exelixis

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: February 23, 2005
• First Submitted That Met QC Criteria: February 23, 2005
• First Posted (Estimate): February 24, 2005

Study Record Updates

• Last Update Posted (Estimate): February 19, 2010
• Last Update Submitted That Met QC Criteria: February 18, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: XL999-001