Study of XL999 in Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00277303
- Lead Sponsor
- Symphony Evolution, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate Inclusion until disease progression Safety and tolerability Inclusion until 30 days post last treatment
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (8)
Joliet Oncology-Hematology Associated, Ltd.
🇺🇸Joliet, Illinois, United States
Hematology Oncology Associates of Rockland, PC
🇺🇸New City, New York, United States
Integrated Community Oncology Network; Division of Clinical Research
🇺🇸Jacksonville, Florida, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Hematology Oncology Associated of the Treasure Coast
🇺🇸Port St. Lucie, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Center for Oncology Research and Treatment, PA
🇺🇸Dallas, Texas, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States