Study of XL999 in Patients With Non-small Cell Lung Cancer

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 non-small cell lung cancer (NSCLC). 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 Non-Small-Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

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 NSCLC Prior treatment with a platinum- or taxane containing regimen Stage IIIB with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy) Measurable disease according to Response Criteria for Solid Tumors (RECIST) 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 Use of any systemic anticancer therapy within 30 days of XL999 treatment More than 2 prior systemic cytotoxic chemotherapy regimens More than 1 prior agent targeted against VEGF or EGFR (eg, bevacizumab, erlotinib, or gefitinib) Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days before study enrollment Uncontrolled and/or intercurrent illness History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis 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|• The Study Treatment Period, in which subjects received a once-weekly, 4-hour intravenous (IV) infusion of XL999 at 2.4 mg/kg as outpatients for 8 weeks. Treatment was to be stopped at the occurrence of disease progression or unacceptable toxicity.|

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 dyas 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 |  | Various time points during the 8-week Study Treatment Period in the second stage of the study |