Table 1.

Summary of Phase I trials designed to evaluate the tolerability and safety of ixabepilone as a single agent in the management of solid tumors refractory to standard therapies, including pancreatic cancer^*

Reference	Patients enrolled (n)	Ixabepilone MTD	Efficacy assessments
Awada et al19	87 (86 actually treated)	Intravenous 25 mg/m2 every 21 days and 20 mg/m2 weekly, on a 28-day cycle	Five of 86 treated patients demonstrated objective partial responses
Shimizu et al20	14	Intravenous 40 mg/m2, every 21 days	Seven of 14 patients demonstrated durable tumor stabilization or shrinkage
He et al21 and Kunz et al22	23	Oral 120 mg, every 21 days (Due to PK variability, oral formulation not pursued further)	Five of 18 treated patients demonstrated stable disease

Note:

^*Clinical efficacy assessments, reported as secondary objectives in these studies, are also summarized above.

Abbreviations: MTD, maximum tolerated dose; PK, pharmacokinetics.