Study of XL999 in Patients With Metastatic Colorectal Cancer

February 18, 2010 updated by: Symphony Evolution, Inc.

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.

Study Overview

Status

Terminated

Conditions

Colorectal Cancer

Intervention / Treatment

Drug: XL999

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Greenbrae, California, United States, 94904
    - California Cancer Care, Inc.
- Florida
  - Jacksonville, Florida, United States, 32256
    - Integrated Community Oncology Network; Division of Clinical Research
  - Port St. Lucie, Florida, United States, 34952
    - Hematology Oncology Associated of the Treasure Coast
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associated, Ltd.
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Cancer Center
- New York
  - New City, New York, United States, 10956
    - Hematology Oncology Associates of Rockland, PC
- Texas
  - Dallas, Texas, United States, 75230
    - Center for Oncology Research and Treatment, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate Time Frame: Inclusion until disease progression	Inclusion until disease progression
Safety and tolerability Time Frame: Inclusion until 30 days post last treatment	Inclusion until 30 days post last treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival Time Frame: Inclusion until disease progression	Inclusion until disease progression
Duration of response Time Frame: Inclusion until disease progression	Inclusion until disease progression
Overall survival Time Frame: Inclusion until last Follow-up post last treatment or death	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	Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symphony Evolution, Inc.

Investigators

Study Director: Lynne Bui, MD, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria