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
  Purpose

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


Condition Intervention Phase
Cancer
Drug: XL999
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: November 2004
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104117

Locations
United States, Ohio
Case Western Reserve University, Univserzity Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
Cancer Therapy and Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Symphony Evolution, Inc.
Investigators
Study Director: Paul Woodard, MD Exelixis, Inc
  More Information

No publications provided

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
ClinicalTrials.gov Identifier: NCT00104117     History of Changes
Other Study ID Numbers: XL999-001
Study First Received: February 23, 2005
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014