Know Cancer

forgot password

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:


Principal Investigator

Lynne Bui, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

February 2007

Related Keywords:

  • Colorectal Cancer
  • Colon Cancer
  • Colorectal Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
California Cancer Care, Inc. Greenbrae, California  94904-2007
University of Chicago Chicago, Illinois  60637
Center for Oncology Research and Treatment, PA Dallas, Texas  75230
Hematology Oncology Associates of Rockland, PC New York City, New York  10956
Integrated Community Oncology Network; Division of Clinical Research Jacksonville, Florida  32256
Hematology Oncology Associated of the Treasure Coast Port St. Lucie, Florida  34952
Joliet Oncology-Hematology Associated, Ltd. Joliet, Illinois  60435