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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: XL999
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: December 2005
Study Completion Date: February 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

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

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
  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: NCT00277303

Locations
United States, California
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
United States, Florida
Integrated Community Oncology Network; Division of Clinical Research
Jacksonville, Florida, United States, 32256
Hematology Oncology Associated of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Joliet Oncology-Hematology Associated, Ltd.
Joliet, Illinois, United States, 60435
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, New York
Hematology Oncology Associates of Rockland, PC
New City, New York, United States, 10956
United States, Texas
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Symphony Evolution, Inc.
Investigators
Study Director: Lynne Bui, MD Exelixis, Inc
  More Information

No publications provided

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
ClinicalTrials.gov Identifier: NCT00277303     History of Changes
Other Study ID Numbers: XL999-206
Study First Received: January 12, 2006
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Symphony Evolution, Inc.:
Colon Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 18, 2014