A	B	C
1	Main
2		Brand Name	Sutent
3		Generic Name	sunitinib
4		Mechanism	TK inhibitor: VEGFR, PDGFR, KIT, FLT-3
5		Administration	Oral
6		Label	GIST, 2L RCC
7		Clinical Studies
8			Phase III - Sutent+Taxol vs Avastin+Taxol in mBC
9			n=740, started 11/2006.
10
11			Phase III FOLFIRI+-Sutent in 1L mCRC "SUN1122" - DISCONTINUED?
12			n=720, started June 2007
13
14			Phase 2 2L/3L NSCLC - ASCO 2007
15			1L RCC: ASCO 2006
16			11mo PFS vs 5mo IFN; 25% RR vs 5%
17			n=750 CCC
18
19		2 sequentially conducted p2 RCC single arm multicenter studies
20		6k new mRCC patients/year??
21		50mg daily 4/6 weeks in predominately cytokine refractory patients
22
23		Motzer et al proc ASCO 23:380s, 2005
24		n=63, accrual 1/03 to 7/03, reported asco 2004, updated as of 12/04
25		40% RR, 0% CR
26		28% SD >3 mo, 25% SD/PD <3 months, 6% non evaluable
27		8.7m TTP, 16.4m MOS
28
29		n=106, accrual 2/04 to 11/04, updated as of 1/05
30		39% RR, 1% CR
31		23% SD>3 mo, 31% SD/PD <3 months, 31% non evaluable
32		TTP/MOS not given yet
33
34		SU11248 in previously treated MBC - Miller et al, ASCO 05 #563
35		50mg qd for 28 days, 14 day rest. Response assessed every 2 cycles. Prior anthracycline and taxane therapy.
36		39% g3 neutropenia, 15% g3 thrombocytopenia. 7/41 patients required dose-reduction. 13/41 required dose interruption.
37		14% PR, 2% SD. 2 PRs not yet confirmed. N=51
38
39		Sutent in lung - ASCO 06
40		3/63 died from bleeding - 2 in the lung, 1 in the brain
41		stopped tumor growth in 43%, shrank in 9.5%.
42		Charles Baum - oncology clinical leader at PFE
43
44
45		Long list of clinical studies.
46
47		Phase III continuation in Breast Neoplasms, Carcinoma, Pancreatic, RCC, GIST
48		still recruiting, began 02/07
49
50		Phase III +/- placebo with advanced pancreatic islet cell tumors. N = 340, still recruting, began 03/07
51
52		Phase III +/- placebo in RCC, n = 228. still recruiting, began 09/07
53
54		Phase III vs Imatinib in GIST, n = 200. Still recruiting, began 07/07
55
56		Phase III Erlotinib +/- Sutent in Non-small cell lung cancer, n = 956. Still recruiting, gegan 06/07
57
58		Phase III vs Capecitabine in advanced breast cancer who failed both a taxane and anthracycline chemotherapy, or failed taxane where anthracycline chemo not needed
59
60
61		Completed Phase III in malignant GIST, n = 357.
62
63		Phase III vs Interferon-Alfa as 1st line therapy in RCC, n = 700. Ongoing
64
65		Phase III + Paclitaxel vs Avastin + Paclitaxel in advanced Breast Cancer
66
67		Phase II:
68		Completed Phase II + Temsirolimus in RCC
69		Stage II or III breast cancer that can be removed surgically
70		n = 700. Still recruiting, began 11/06
71		Neoadjuvant sutent in RCC
72		Adjuvant sutent following chemotherapy, radiation, and surgery for esophageal cancer
73		In nonclear cell RCC
74		Dosage efficacy in first line metastic RCC
75		Male patients with relapsed or cisplatin-refractory germ cell cancer
76		Prostate cancer
77		Colorectal cancer
78		Metastic and/or surgically unresectable soft tissue sarcoma
79		Thyroid carcinoma
80		Following gepatic artery embolization
81		VHL
82		After taxanes in metastic breast cancer
83		Cytokin-Refractory metastic RCC
84		Advanced prostate cancer
85		Myelodysplastic syndromes
86		Metastic, locally advanced or recurrent Sarcomas
87		Advanced Hepatocellular Carcinoma
88		Kaposi Sarcoma, treating East African Patients
89		Rafractory adrenocortical carcinoma
90		Locally advanced bladder cancer
91		+ Chemoembolization in Liver cancer that cannot be removed surgically
92		+ Lenalidomide + Cyclophospharride in State IV Eye Melanoma
93		Advanced breast cancer
94		Relapsed multiple Myeloma
95		Advanced Malignant Pleural mesothelioma
96		Brain metastases caused by RCC or Melanoma
97		Thyroid cancer that did not respond to Iodine I 131 and cannot be removed surgically
98		Metastic cervical cancer, unresectable, locally advanced
99		Metastic recurrent ovarian epithelieal, fallopian tube, or peritoneal cancer
100		Relapsed or refracotry diffuse or mediastinal large B-Cell lymphoma
101		Metastic pancreatic cancer that progressed after 1st line therapy with Gemcitabine
102		Panzem NCD +/- Sutent in metastic RCC
103		+ Tamoxifen + Cisplatin in high risk Ocular melanoma
104		Relapsed or refractory chronic Lymphocytic Leukemia or small LL
105		+ Docetaxel and Prednisone in Prostate cancer
106		Phase III vs Sorafenib in RCC removed by surgery
107		In metastic Gastric cancer
108		+ Erlotinib in unresectable or metastic RCC
109		+ Gemcitabine in pancreatic and other solid tumors
110		+ combination chemo before surgery, stage II and III breast cancer
111		Metastic and/or surgically unresectable Hepatocellular
112		Erlotinib +/- Sutent In non small cell lung cancer
113		Idiopathic Myelofibrosis
114		Recurrent malignant Gliomas
115		Recurrent or metastic Endometrial cancer
116		Locally recurrent or metastic Kidney cancer
117		Progressive metastic transitional cell cancer of the Urothelium
118		Liver cancer that cannot be moved surgically.
119		Recurrent and/or head and neck cancer
120		Kdney Cancer that cannot be removed surgically
121		Unresectable or metastic Kidney Cancer or other advanced Solid tumors.
122		Germ Cell tumors that have relapsed or not responded to treatment
123		Locally advance or metastic non small cell lung cancer. Ongoing
124		International Phase II in Inoperable Liver Cancer
125		Advanced/metastic Gastric Cancer failing Chemotherapy
126		Gortec head and neck Carcinoma
127		Neuroendocrine tumors. Ongoing
128		Avasti-refractory mestatic RCC. Ongoing
129
130
131
132		Suspended in Recurrent or persistent Leiomyoxarcoma of the Uterus
133		Suspended Phase I in Refractory solid tumors
134		Suspended SABRE- studies due to combination toxicity with Avastin.
135
136
137
138		Phase I in GIST
139		Phase I and II in Melanoma
140
141			Phase I + Avastin in RCC - Published in JCO 2009
142			Too toxic to use in combination with Avastin. High degree of HTN, vascular and hematologic toxicities.