Table 3.

Clinical trials of DNMTi for urological cancers.

Drug	Clinical trial identifier	Phase	Status	Protocol	Outcome
Prostate
Vidaza	NCT00384839	Phase II	Completed	CRPC cases on combined androgen blockade with PSA-DT<3 months treated with 75 mg/m2 s.c. on days 1–5 of each 28 day cycle for up to 12 cycles where tolerable. n=36	PSA-DT>3 months achieved in 55.8% patients; median progression free survival=12.4 weeks
Decitabine	–	Phase II	Completed	Metastatic cases post-total blockade and flutamide withdrawal were treated with 57 mg/m2/dose i.v. as 1 h infusion every 8 h for 3 doses; cycles repeated every 5–8 weeks. n=14	17% had stable disease with progression time>10 weeks
Vidaza, docetaxel and prednisone	NCT00503984	Phase I/II	Recruiting	CRPC patients previously treated with docetaxel. Azacitidine: i.v., days 1–5 of each 3 weekly cycle; docetaxel: i.v. on day 6 of each 3 weekly cycle; prednisone: 5 mg twice daily from day 1 to 21 of each cycle. Predicted enrolment: n=42	NYA
Bladder & testes
Decitabine	NCT00030615	Phase I	Completed	Advanced bladder and testicular cancer patients received daily escalating doses of decitabine for 4 weeks until MTT was determined.	NYA
Kidney
Vidaza, bevacizumab	NCT00934440	Phase I/II	Recruiting	Advanced RCC patients receiving: bevacizumab at standard dose of 10 mg/kg IV every two weeks; vidaza: several different doses s.c. dependent on phase I/II. Predicted enrolment: n=23	NYA
Decitabine, IFNα-2B	NCT00561912	Phase II	Terminated	Advanced RCC patients received decitabine: 15 mg/m2 i.v. daily for 5 days; IFNα-2B s.c. twice daily continuously as of day 1 cycle 3.	Terminated due to poor accrual (n=2)
MG98	NCT00003890	Phase I/II	Terminated	Untreated metastatic RCC patients received 360 mg/m2/dose i.v. twice weekly for 3 out of 4 weeks. n=17	No conclusive pattern of decreased DNMT1 activity in PBMCs was detected post MG98 treatment. Terminated due to toxicity.

Abbreviations: MTT: maximum tolerated dose, PBMCs: peripheral blood mononuclear cells, and NYA: not yet available.