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Accelerated titration designs - Biometric Research Branch

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~~.."" . -" .-~---~-~~.~_...<br />

0<br />

.-<br />

.t<br />

Table 4.3 ( Continued)<br />

Intra patient<br />

dose- Recommended<br />

Author/<br />

reference Agent Schedule Design escalation dose<br />

Borchmann H22xKi-4, bispecific IV days 1,3,5, 4B Yes 80 mg/m2 per cycle<br />

et al. (29) anti-CD30 and CD64 7-21 days<br />

monoclonal antibody<br />

0 ZC/<br />

C/ ..<br />

Gadgeel KRN5500, spicamycin 1 hour iV daily x 5 2B Yes 4.3 mg/m2/day x 5 every<br />

et al. (30) derivative every 3 weeks<br />

3 weeks<br />

Schoemaker MAG-CPT, polymer IV infusion over 3 days Modified 2A No 68 mg/m2/day for 3 days<br />

et at. (31) conjugate of every 4 weeks<br />

every 4 weeks<br />

camptothecin<br />

Matsumura MCC-465, doxorubicin 1 hour IV infusion every ATD No 32.5 mg/m2 every 3 weeks ~<br />

et al. (32) PEG immunoliposome 3 weeks planned n<br />

Clive Antagonist G substance P IV every 3 weeks until Modified 4A No 400 mg/m2 weekly 6 hour<br />

~<br />

et al. (33) analog the target maximum<br />

IV infusion<br />

plasma concentration<br />

~<br />

of 10 p,M then weekly<br />

~<br />

Matsumura NK9l1, micelle IV every 3 weeks Modified 3A No 50 mg/m2 every 3 weeks i- -i et at. (34) encaps!llated doxorubicin<br />

de Jonge PNU -159548, alky1cycline IV every 3 weeks Modified 4B Yes 12 and 14 mg/m2 IV every ~<br />

3 weeks in HP and MP -<br />

et al. (35)<br />

(2 studies)<br />

0<br />

patients<br />

Z<br />

ci<br />

Lockhar PNU -166196A, brostallcin, IV weekly x 3 every Modified 3B Yes 2.4 mg/m2/week tI<br />

et al. (36) a nonalkylating DNA 4 weeks<br />

minor groove binder<br />

';;.::,:,¡:<br />

\~;i::;\,~,.:" .<br />

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