Renal Cell Carcinoma
Conditions
Keywords
Kidney cancer, Metastatic
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.
Interventions
DRUGXL999
Treatment was administered on an outpatient basis. XL999 was administered at a dose of 2.4 mg/kg given as a 4 hour IV infusion.
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 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
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 180-day Follow-up post last treatment or death |
| Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters | Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment. |
Countries
United States
Outcome results
None listed