Table 1.

Clinical trials investigating the efficacy and safety/tolerability of sunitinib against different cancer types.

Tumor type	Clinical status	Therapeutic combination	ClinicalTrials.gov identifier	Notes
Relapsed or refractory esophageal or gastro-esophageal junction cancer.	Phase II	Monotherapy	NCT00702884	Sunitinib was well tolerated but only a subset of treated patients benefited [10 out of 25 (42%) had stable disease > 10 weeks] (Wu et al., 2015).
Extensive-stage small cell lung cancer.	Phase II	Sunitinib as a maintenance therapy following induction platinum + etoposide based therapy	NCT00616109	Sunitinib did not maintain disease stability following response to chemotherapy (only 4/16 [25%] patients had stable disease). Sunitinib was discontinued due to disease progression (50%), toxicity (31%), and patient request (19%) (Schneider et al., 2011).
Metastatic breast cancer.	Phase II	Monotherapy	NA	Sunitinib was modestly active in patients with heavily pretreated metastatic breast cancer (11% partial response and 5% stable disease). Most adverse effects were mild-to-moderate and managed with supportive treatment and/or dose modification (Burstein et al., 2008).
Refractory or relapsed small cell lung cancer.	Phase II	Monotherapy	NCT00620347	Partial tumor response was reported in 2 out of 23 patients, The median progression free survival was short and sunitinib was not tolerated in most patients did not tolerate sunitinib (Han et al., 2013).
Relapsed or refractory germ cell tumor (resistant to standard platinum-based chemotherapy)	Phase II	Monotherapy	NCT00453310	Sunitinib was well tolerated, but at standard doses, did not demonstrate significant activity in highly refractory germ cell tumor (no objective responses were found and all patients developed progressive disease within three cycles of sunitinib) (Feldman et al., 2010).
Local or metastatic papillary and non-clear cell renal cancer.	Phase II	Monotherapy	NCT00459875	Out of 22 evaluated patients, only one partial response was observed in unclassified metastatic renal cell carcinoma patient. No objective responses were found in patients with papillary metastatic renal cell carcinoma and non-clear cell histologies (Molina et al., 2013).
Non-clear cell renal cancer.	Phase II	Monotherapy	NCT00465179	Out of 55 analyzed enrolled patients, three had partial response, 29 and 23 had stable and progressive diseases respectively.
Cytokine refractory metastatic renal cell carcinoma.	Phase II	Monotherapy	NCT00077974	Sunitinib demonstrated efficacy and manageable adverse-event profile as a monotherapy in second-line therapy for patients with cytokine-refractory metastatic clear-cell RCC (Motzer et al., 2006).
Progressive metastatic transitional cell cancer of the urothelium.	Phase II	Monotherapy	NCT00397488	3 out of 71 patients had partial response. 29/71 (40.9%) had stable disease. Almost 55% (39/71) progressed.
Advanced prostate cancer.	Phase II	Monotherapy	NCT00299741	Sunitinib was well tolerated with modest benefit (Michaelson et al., 2009).
Metastatic colorectal cancer.	Phase II	In combination with capecitabine	NCT00961571	This study was terminated due to unanticipated side effects and futility.
Brain metastases caused by kidney cancer or melanoma.	Phase II	Monotherapy	NCT00462982	Out of the five patients who completed the study, three had stable disease and two progressed.
Imatinib resistant metastatic dermatofibrosarcoma protuberan.		Prior to sunitinib, patients could undertake other chemotherapy, radiotherapy and local surgery.	NA	Out of 30 imatinib-resistant patients, two had complete response (6.7%), 10 had partial response (33.3%), 12 had stable disease (40%) and 6 porgressed (20%). The progression free survival of complete response and partial response patients were 22 months and 20 months respectively. Hence, sunitinib therapy conferred good clinical efficacy and tolerated adverse effects as a new in imatinib resistant dermatofibrosarcoma protubern (Fu et al., 2015).
Metastatic mucosal or acral melanoma.	Phase II	Monotherapy	NCT00577382	Sunitinib was active against mucosal and acral melanoma that was independent of KIT mutation. Nevertheless, it was poorly tolerated, and with no prolonged responses (Buchbinder et al., 2015).
Recurrent, refractory, or progressive malignant glioma or ependymoma.	Phase II	Monotherapy	NCT01462695	Sunitinib was well tolerated in children and young adults with recurrent high- grade glioma or ependymoma. Sunitinib therapy significantly modulated plasma VEGFR2. Nevertheless, there were no sustained antitumor responses (Wetmore et al., 2016).
Metastatic, locally advanced, or locally recurrent sarcomas (non-gastrointestinal stromal tumor sarcoma).	Phase II	Monotherapy	NCT00474994	One patient achieved a confirmed partial response. 10 patients (20%) achieved stable disease for at least 16 weeks. There were no unexpected toxicities observed (George et al., 2009).
Metastatic pancreatic cancer.	Phase II	Monotherapy -maintenance therapy	NCT00967603	Results have not published yet.
Recurrent or inoperable meningiomas.	Phase II	Monotherapy	NCT00589784	Out of 35 analyzed patients with aggressive meningiomas, one had complete response, one had partial response, 25 had stable disease and eight progressed. The four patients with WHO grade I meningioma and hemangioblastoma treated with sunitinib progressed.
Advanced gastric cancer.	Phase II	Together with docetaxel	NCT01238055	Results have not published yet.
Inoperable liver cancer.	Phase II	Monotherapy	NCT00699374	Continuous daily sunitinib treatment (37.5 mg) was feasible and had moderate activity in patients with advanced hepatocellular carcinoma (Koeberle et al., 2010).
Myelodysplastic syndromes or chronic myelomonocytic leukemia.	Phase II	Monotherapy	NCT00451048	10 patients completed the study, but no statistical analysis is provided for the overall response Rate (complete response, partial response, or hematologic improvement).
Persistent or recurrent clear cell ovarian cancer.	Phase II	Monotherapy	NCT00979992	Out of 30 analyzed patients, the % of objective tumor response rate (complete and partial response) is 6.7.
Advanced urothelial carcinoma.	Phase II	Monotherapy	NCT00393796	Maintenance sunitinib did not appear to improve the 6-month progression rate. Open-label sunitinib had only modest activity (Grivas et al., 2014).

NA: Not available.