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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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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:

Interventional

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:

No

Principal Investigator

Lynne Bui, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

XL999-206

NCT ID:

NCT00277303

Start Date:

December 2005

Completion Date:

February 2007

Related Keywords:

  • Colorectal Cancer
  • Colon Cancer
  • Colorectal Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
California Cancer Care, Inc.Greenbrae, California  94904-2007
University of ChicagoChicago, Illinois  60637
Center for Oncology Research and Treatment, PADallas, Texas  75230
Hematology Oncology Associates of Rockland, PCNew York City, New York  10956
Integrated Community Oncology Network; Division of Clinical ResearchJacksonville, Florida  32256
Hematology Oncology Associated of the Treasure CoastPort St. Lucie, Florida  34952
Joliet Oncology-Hematology Associated, Ltd.Joliet, Illinois  60435