Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: XL999


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: XL999|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.|

What is the study measuring?
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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 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney cancer, Metastatic