Study of XL999 in Adults With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00104117
First received: February 23, 2005
Last updated: February 18, 2010
Last verified: February 2010

February 23, 2005
February 18, 2010
November 2004
September 2008   (final data collection date for primary outcome measure)
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 [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00104117 on ClinicalTrials.gov Archive Site
  • To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors [ Time Frame: Various timepoints from pre-dosing until 48 hours post dose. ] [ Designated as safety issue: Yes ]
  • To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg. [ Time Frame: At various timepoints from pre-dosing until 48 hours post dosing ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
October 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00104117
XL999-001
Yes
Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Symphony Evolution, Inc.
Not Provided
Study Director: Paul Woodard, MD Exelixis, Inc
Symphony Evolution, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP