NCT00277303

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

8 months

First QC Date

January 12, 2006

Last Update Submit

February 18, 2010

Conditions

Colorectal Cancer

Keywords

Colon Cancer

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Inclusion until disease progression

  • Safety and tolerability

    Inclusion until 30 days post last treatment

Secondary Outcomes (4)

  • Progression-free survival

    Inclusion until disease progression

  • Duration of response

    Inclusion until disease progression

  • Overall survival

    Inclusion until last Follow-up post last treatment or death

  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters

    Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study

Interventions

XL999DRUG

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

California Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

Integrated Community Oncology Network; Division of Clinical Research

Jacksonville, Florida, 32256, United States

Location

Hematology Oncology Associated of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Joliet Oncology-Hematology Associated, Ltd.

Joliet, Illinois, 60435, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Hematology Oncology Associates of Rockland, PC

New City, New York, 10956, United States

Location

Center for Oncology Research and Treatment, PA

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Lynne Bui, MD

    Exelixis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

December 1, 2005

Primary Completion

August 1, 2006

Study Completion

February 1, 2007

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

US(8)