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Study of XL999 in Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XL999
Sponsored by
Symphony Evolution, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Cancer Care, Inc.
  • Integrated Community Oncology Network; Division of Clinical Research
  • Hematology Oncology Associated of the Treasure Coast
  • University of Chicago
  • Joliet Oncology-Hematology Associated, Ltd.
  • Indiana University Cancer Center
  • Hematology Oncology Associates of Rockland, PC
  • Center for Oncology Research and Treatment, PA

Outcomes

Primary Outcome Measures

Response rate
Safety and tolerability

Secondary Outcome Measures

Progression-free survival
Duration of response
Overall survival
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters

Full Information

First Posted
January 12, 2006
Last Updated
February 18, 2010
Sponsor
Symphony Evolution, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00277303
Brief Title
Study of XL999 in Patients With Metastatic Colorectal Cancer
Official Title
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to cardiac toxicities in the subjects
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Symphony Evolution, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
XL999
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Inclusion until disease progression
Title
Safety and tolerability
Time Frame
Inclusion until 30 days post last treatment
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Inclusion until disease progression
Title
Duration of response
Time Frame
Inclusion until disease progression
Title
Overall survival
Time Frame
Inclusion until last Follow-up post last treatment or death
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Bui, MD
Organizational Affiliation
Exelixis
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Integrated Community Oncology Network; Division of Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Hematology Oncology Associated of the Treasure Coast
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Joliet Oncology-Hematology Associated, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Hematology Oncology Associates of Rockland, PC
City
New City
State/Province
New York
ZIP/Postal Code
10956
Country
United States
Facility Name
Center for Oncology Research and Treatment, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of XL999 in Patients With Metastatic Colorectal Cancer

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