Table 3.

Efficacy of Single Agent Ixabepilone in Phase II Trials

Tumor Type	Pretreatment/Resistance	N*	Response Rate	Ref.
Bladder	Both taxane-pretreated and - naive	37	14% (8% pretreated)	49
Breast, early stage	Treatment-naive	96	19%(pCR†)	36
Breast, metastatic	Taxane-naive	23	57%	37
Breast, locally advanced  or metastatic	Taxane-pretreated	37	22%	38
Breast, metastatic	Anthracycline-pretreated	65	41.5%	39
Breast, metastatic	Taxane-resistant	49	12%	40
Breast, metastatic (29% “triple negative”)	Anthracycline-, taxane-, and capecitabine-resistant	113	18.6%	41
Colorectal, advanced	Irinotecan/5- fluorouracil/leucovorin- refractory	25	0%	55
Gastric	Taxane-pretreated	45	4%	50
Gynecologic and Breast	Almost all taxane-pretreated	21	14% (31% in breast )	51
Head and Neck, squamous cell, recurrent or metastatic	Mixed taxane-naive and -exposed (2 arms with different dosing)	75 (Arm A: 32; Arm B 43)	A: 0%; B: 14.3% (of taxane-naive)	52
Hepatobiliary (75% metastatic)	Chemotherapy-naive	48	8%	53
Melanoma, stage IV	50% untreated, 50% pretreated	23	0%	56
NHL, relapsed agressive	All heavily pretreated	14	73% remission rate	42
NHL, indolent and mantle cell	Resistant disease (≤4 prior treatments)	11	14%	43
NSCLC	Platinum-refractory	112 (Arm A: 52; Arm B: 60)	14% (A); 12% (B)	44
Pancreatic, advanced	Chemotherapy-naive	56	9%	45
Prostate, metastatic	Hormone-refractory, chemotherapy-naive	42	15% (33% PSA)	46
Prostate, metastatic, with (−) or without (+) extramustine phosphate (EMP)	Progressive castrate, chemotherapy naive	48 (25 −EMP; 23 +EMP)	32% -EMP (48% PSA); 48% +EMP (68% PSA)	47
Renal	Prior systemic immune therapy (39%); prior nephrectomy (91%)	57	14%	48
Sarcoma, advanced or metastatic	Adjuvant chemotherapy (39%); chemotherapy-naive metastatic disease	31	6%	54

^*Evaluable patients

^†pCR pathologic complete response