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Study of XL999 in Patients With Metastatic Colorectal Cancer

This study has been terminated.
(Study was terminated due to cardiac toxicities in the subjects)
Sponsor:
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00277303
First received: January 12, 2006
Last updated: February 18, 2010
Last verified: February 2010

January 12, 2006
February 18, 2010
December 2005
August 2006   (final data collection date for primary outcome measure)
  • Response rate [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]
  • Response rate
  • Safety and tolerability
Complete list of historical versions of study NCT00277303 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Inclusion until last Follow-up post last treatment or death ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters [ Time Frame: Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study ] [ Designated as safety issue: Yes ]
  • Progression-free survival
  • Duration of response
  • Overall survival
  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
Not Provided
Not Provided
 
Study of XL999 in Patients With Metastatic Colorectal Cancer
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer (CRC). 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: XL999
XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
February 2007
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females with histologically confirmed metastatic colorectal cancer
  • Measurable disease according to Response Criteria for Solid Tumors (RECIST)
  • At least 1 prior therapeutic regimen (chemotherapy or biologic)
  • ECOG performance status of 0 or 1
  • Life expectancy ≥3 months
  • Adequate organ and marrow function
  • No other malignancies within 5 years
  • Signed informed consent

Exclusion Criteria:

  • Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
  • Treatment with systemic anticancer therapy within 30 days of XL999 treatment
  • Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days prior to study enrollment
  • History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
  • Uncontrolled and/or intercurrent illness
  • Pregnant or breastfeeding females
  • Known HIV
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00277303
XL999-206
Yes
Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Symphony Evolution, Inc.
Not Provided
Study Director: Lynne Bui, 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