Study of XL999 in Patients With Previously Treated Ovarian Cancer

Study Overview
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Brief Summary
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This clinical trial is being conducted at multiple sites to evaluate the activity, safety, and tolerability of XL999 when given weekly to patients with ovarian cancer that has previously been treated with platinum-based chemotherapy. 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 Recurrent Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: XL999


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients with a histologically confirmed diagnosis of metastatic ovarian cancer Measurable disease according to Response Criteria for Solid Tumors (RECIST) Prior treatment with platinum-based therapy Platinum-sensitive or platinum-resistant disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of ≥3 months Adequate organ and marrow function Signed informed consent No other malignancies within 5 years Exclusion Criteria: Radiation to ≥25% of bone marrow within 30 days of XL999 treatment Use of an investigational drug or cytotoxic chemotherapy within 30 days of XL999 treatment Prior anticancer therapy targeting VEGF (eg, bevacizumab, sorafenib, or sunitinib) More than two prior systemic non-platinum cytotoxic chemotherapy regimens 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 Patients who are pregnant or breastfeeding Known human immunodeficiency virus (HIV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 2.4 mg/kg as a 4 hour intravenous (IV) infusion. Subjects received a XL999 infusion once a week for 8 weeks of treatment unless drug-related toxicity required a dosing delay|

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 after last treatment or death | 
| Pharmacokinetic (PK) and pharmacodynamics (PD) parameters |  | Samples will be collected pre-dose and immediatelyat the end of infusion for the 8-week Study Treatment Period for subjects in the second stage of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Recurrent, Platinum-resistant, Platinum-sensitive