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Study of XL999 in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00277303
Recruitment Status : Terminated (Study was terminated due to cardiac toxicities in the subjects)
First Posted : January 16, 2006
Last Update Posted : February 22, 2010
Sponsor:
Information provided by:
Symphony Evolution, Inc.

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 16, 2006
Last Update Posted Date February 22, 2010
Study Start Date  ICMJE December 2005
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2010)
  • Response rate [ Time Frame: Inclusion until disease progression ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • Response rate
  • Safety and tolerability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • Progression-free survival [ Time Frame: Inclusion until disease progression ]
  • Duration of response [ Time Frame: Inclusion until disease progression ]
  • Overall survival [ Time Frame: Inclusion until last Follow-up post last treatment or death ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • Progression-free survival
  • Duration of response
  • Overall survival
  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of XL999 in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 15, 2010)
17
Original Enrollment  ICMJE
 (submitted: January 12, 2006)
40
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00277303
Other Study ID Numbers  ICMJE XL999-206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Study Sponsor  ICMJE Symphony Evolution, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lynne Bui, MD Exelixis
PRS Account Symphony Evolution, Inc.
Verification Date February 2010

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