Clinical trial NCT00277303: Study of XL999 in Patients With Metastatic Colorectal Cancer
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colon Cancer
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Response rate
timeFrame: Inclusion until disease progression
measure: Safety and tolerability
timeFrame: Inclusion until 30 days post last treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: Inclusion until disease progression
measure: Duration of response
timeFrame: Inclusion until disease progression
measure: Overall survival
timeFrame: Inclusion until last Follow-up post last treatment or death
measure: Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
timeFrame: Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network; Division of Clinical Research
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associated of the Treasure Coast
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associated, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: New City
country: United States
facility: Hematology Oncology Associates of Rockland, PC
state: New York
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment, PA
state: Texas
Study officials:
affiliation: Exelixis
name: Lynne Bui, MD
role: STUDY_DIRECTOR
References: