Study of XL999 in Patients With Metastatic Colorectal Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: XL999


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Inclusion until disease progression | 
| Safety and tolerability |  | Inclusion until 30 days post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon Cancer