A phase II study of XL999 in patients (pts) with NSCLC
| Autor: | M. Wertheim, R. J. March, S. Modi, B. Mirtsching |
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| Rok vydání: | 2007 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 25:18112-18112 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 18112 Background: XL999 is a potent spectrum-selective inhibitor of receptor tyrosine kinases including VEGFR2/KDR, FGFR1/3, PDGFR-β, FLT3, RET, KIT, & SRC. A Ph 1 clinical study in pts w/advanced malignancies evaluating weight-based (0.2 - 6.4 mg/kg) & fixed dose (200 mg & 160 mg) XL999 administered by 4hr IV infusion on a wkly or every other wk schedule has shown preliminary evidence of anti- tumor activity (3 PRs & 10 pts w/SD lasting 3–26+ months). The safety profile was characterized by hypertension & cardiovascular changes including EKG, LVEF decrease &/or cardiac enzyme elevation following 1st dose administration. DLTs were cardiac failure & transaminase elevation. A dose of 2.4 mg/kg/wk was selected for phase II evaluation. Methods: The 1 objectives of this phase II study are to determine the RR & to further evaluate the safety & tolerability of XL999. Adult pts w/NSCLC (stage IIIB with malignant effusion, stage IV, or recurrent) & previously treated with no more than 2 prior systemic cytotoxic chemotherapy regimens, including a platinum-or taxane-containing regimen, & no more than one prior target agent targeting VEGF or EGFR, are eligible. Additional inclusion criteria include ECOG PS 0–1 & absence of known brain metastases. Pts with LVEF No significant financial relationships to disclose. |
| Databáze: | OpenAIRE |
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