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Study was terminated due to cardiac toxicities in the subejcts
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XL999 | Drug | • 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Inclusion until disease progression | |
| Safety and tolerability | Inclusion until 30 dyas post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Inclusion until disease progression | |
| Duration of response | Inclusion until disease progression | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Woodard, MD | Exelixis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology/Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | United States | ||
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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 |
| Joliet Oncology-Hematology Associates, Ltd. |
| Joliet |
| Illinois |
| 60435 |
| United States |
| Hematology-Oncology Associates of Rockland | Nyack | New York | 10960 | United States |
| Center for Oncology Research and Treatment, PA | Dallas | Texas | 75230 | United States |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |