专利摘要:

公开号:ES2566973T9
申请号:ES10177951.0T
申请日:2005-03-14
公开日:2017-01-03
发明作者:Daniel C. Adelman;Jeffrey A. Silverman;Higaki Masaru;Nakao Satoshi
申请人:Sumitomo Dainippon Pharma Co Ltd;Sunesis Pharmaceuticals Inc;
IPC主号:
专利说明:

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Solution includes the following to prepare a 100 mg / 10 mL presentation: 100 mg of SNS-595 and 450 mg of Dsorbitol are added to distilled water; the volume is brought to a volume of 10 mL; and the pH of the resulting solution is adjusted to 2.5 with methanesulfonic acid. The resulting composition is also suitable for lyophilization. The lyophilized form is then reconstituted with sterile water to the appropriate concentration before use.
5 Example 2
Pharmacokinetics of SNS-595 in cancer patients
SNS-595 was administered to patients included in up to six cycles. A cycle is defined as a three-week period, administering SNS-595 on the first day of each cycle (day 0), followed by at least 21 days of observation. SNS595 was administered to cohorts of at least 3 patients and dose escalation was performed by cohorts consecu
10 tives The doses of SNS-595 were linear with AUC∞ and their pharmacokinetic properties were remarkably constant among patients of the same cohort. Figure 1 represents the plasma concentrations of SNS595 in relation to the time between the various patient cohorts and Table 1 shows the pharmacokinetic parameters derived from them.
Table 1
Dose, mg / m2 Hl hoursCO ng / mLCmax ng / mLLast AUC h-1ng / mLAUC INF_ obs h-1ng / mLCL_obs mL / min / kgVz_obs L / kgVss_ obs L / kgMRTINF_obs h
3 16.27152.25138.80750.081139.551.141.551.4421.96
S.D 4,87182,28280,56887,6222630.3180.2970.2776,836
6 20.69379.69347.002400.002890.290.711.981.2429.05
S.D 0,327243,598214.96170,556245.640.1530.2950.2181.15
12 17.812888.602246.675395.536329.150.761.171.0723.67
S.D 3,8961302.711065,145292,281181,8040.1260.2580.1845,021
24 16.142884,7022703.3311133.0312655.320.831.151.0621.65
S.D 2,601189,8772573.02488,453851,4580.1080.1240.1655,261
48 21.321964.522868.0021098.5327347.360.991.571.4628.90
S.D 6.32189,8772379,8999405,34614372,7870.6180.5670.478.91
60 17.634797.474537.5928112.1733616.180.831.201.0823.71
S.D 4.151947.891947.899127.1213081.440.3520.370.2186.93
7
权利要求:
Claims (1)
[1]
image 1
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法律状态:
优先权:
申请号 | 申请日 | 专利标题
US55357804P| true| 2004-03-15|2004-03-15|
US553578P|2004-03-15|
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