Colorectal Cancer
Conditions
Keywords
Colon Cancer
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.
Interventions
DRUGXL999
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.
Sponsors
Symphony Evolution, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | Inclusion until disease progression |
| Safety and tolerability | Inclusion until 30 days post last treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed