2011
DOI: 10.1200/jco.2011.29.15_suppl.e13570
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Phase I clinical trial of namitecan (ST1968): Results with D1-3 q3wks schedule.

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“…The present analysis quantified all population PK and PD parameters to evaluate the safety of various dose levels of namitecan, taking into account the variability between patients. Namitecan was found to exhibit a long terminal elimination phase, resulting in an average half‐life of 48 h, slightly higher compared with what has been estimated in the ST1968‐DM‐09‐001 study (40–45 h) . Therefore, the terminal half‐life of namitecan is substantially longer compared with the well known topoiromerase I inhibitors, topotecan (2–3 h) and irinotecan (10 h).…”
Section: Discussionmentioning
confidence: 72%
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“…The present analysis quantified all population PK and PD parameters to evaluate the safety of various dose levels of namitecan, taking into account the variability between patients. Namitecan was found to exhibit a long terminal elimination phase, resulting in an average half‐life of 48 h, slightly higher compared with what has been estimated in the ST1968‐DM‐09‐001 study (40–45 h) . Therefore, the terminal half‐life of namitecan is substantially longer compared with the well known topoiromerase I inhibitors, topotecan (2–3 h) and irinotecan (10 h).…”
Section: Discussionmentioning
confidence: 72%
“…With a target for DLT of <20%, the recommended dose was defined as namitecan 12.5 mg for the D1,8 regimen, 23 mg for the once every 3 week (D1) regimen and 7 mg for the D1–3 regimen. This is somewhat lower compared with the recommended 15 mg dose for the D1,8 regimen and one dose level higher for the D1–3 dosing regimen . With regards to the D1,8 dosing regimen, the next higher simulated dose of namitecan (15 mg) produced an estimated rate of DLT of 21%, which is close to the target.…”
Section: Resultsmentioning
confidence: 86%
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