Clinical trial NCT00277316: Study of XL999 in Patients With Metastatic Renal Cell Carcinoma
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Kidney cancer
Metastatic
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 11
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 clear cell renal cell carcinoma (RCC). 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 clear cell RCC
* Measurable disease according to Response Criteria for Solid Tumors (RECIST)
* No prior systemic cytotoxic chemotherapy
* Subjects who have received either no prior therapy for RCC, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting VEGF or a VEGFR (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
* 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
* Subjects who have received systemic anticancer therapy within 30 days of XL999 treatment
* Subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to 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 180-day Follow-up post last treatment or death
measure: Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
timeFrame: Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Department of Hematology/Oncology
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd
state: Illinois
city: Indianapolis
country: United States
facility: Division of Hematology/Oncology, Indiana University Cancer Center
state: Indiana
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation Taussig Cancer Center
state: Ohio
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment, PA
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
Study officials:
affiliation: Exelixis
name: Lynne A. Bui, MD
role: STUDY_DIRECTOR
References: