SPIRE – combining SGI-110 with cisplatin and gemcitabine chemotherapy for solid malignancies including bladder cancer: study protocol for a phase Ib/randomised IIa open label clinical trial

Table 1 Treatment schedule over 21-day cycle

Day	1	2	3	4	5	8	15	16	17	18	19	20	21
SGI-110	X	X	X	X	X
Cisplatin						X
Gemcitabine						X	X
(Granulocyte-colony stimulating factor)^a							(X)	(X)	(X)	(X)	(X)	(X)	(X)

^aColony stimulating factor (G-CSF) administration: Patients in the initial dose level cohorts in the Dose Escalation Phase will not receive G-CSF as primary prophylaxis. If a patient in those initial cohorts is deemed to require G-CSF for a subsequent treatment cycle then they will discontinue SGI-110 and further use of cisplatin/gemcitabine will be at the discretion of the local investigator.Subsequent dose level cohorts may have G-CSF incorporated as primary prophylaxis for all patients according to the rules described under section 3.5. All subsequent patients will then have G-CSF (e.g. filgrastim or local equivalent) incorporated at a dose of 300 μg SC daily for 7 days from day 15 of each cycle

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