Study of XL999 in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00277303
• Other study ID #: XL999-206
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: February 18, 2010
• Start date: December 2005
• Est. completion date: February 2007

Study information

• Verified date: February 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• XL999
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Inclusion until disease progression	No
Primary	Safety and tolerability		Inclusion until 30 days post last treatment	Yes
Secondary	Progression-free survival		Inclusion until disease progression	No
Secondary	Duration of response		Inclusion until disease progression	No
Secondary	Overall survival		Inclusion until last Follow-up post last treatment or death	No
Secondary	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	Yes