Table 2. Phase I/II clinical trials with satraplatin in numerous solid tumor malignancies [67-71].

Study	Type	Tumor type	Combination drugs	Doses of combination drugs	No. of patients	Results
Sessa et al., 1998 [67]	I	AST	S and C	S 60 mg/m2/day Days 1 – 5 C 1650 mg/m2/day Days 8 – 21 of 35-day cycle	38	MTD: S – 70 mg/m2 C – 2000 mg/m2
Wisinski et al., 2008 [68]	I	AST	S and C	S 60 mg/m2/day Days 1 – 5 with escalation in dose by 20 mg/m2 as tolerated C 1650 mg/m2/day from Days 1 – 14 of 21-day cycle	22	MTD – 100 mg/m2 Stable disease – 54%
Paola et al., 2009 [69]	I	AST	S and Gem	Group A* – Gem 800 mg + S 40 mg Group B – Gem 800 mg + S 60 mg Gem given on Days 1, 8 and 15 q28 d; S from day 1 – 5	17	Good antitumor activity with acceptable toxicity profile
Leal et al., 2008 [70]	I	AST	S and Tax	Tax 60 mg/m2 S 50 mg/m2/day, Days 1 – 5 of a 21-day cycle	23	Encouraging results; recommended for Phase II trials‡ with or without G-CSF
Thompson et al., 2008 [71]	II	NSCLC	S and P	S 80 mg/m2/day Days 1 – 5, P 200 mg/m2 i.v. Day 1 every 28-day cycle for 6 cycles	22	ORR – 21% (1 complete and 6 partial responses) SD – 24% (8 patients) PD – 42% (14 patients)

^*Group A (6 patients), with prior chemotherapy – Gem 800 mg + S 40 mg; Group B (6 patients), with no prior chemotherapy – Gem 800 mg + S 60 mg.

^‡Recommended Phase II dose in repeated three cycles: without G-CSF – Tax, 60 mg/m² i.v. Day 1 with SA 40 mg/m² p.o. Days 1 – 5; with G-CSF, Tax 70 mg/m² i.v. Day 1 with SA 50 mg/m² p.o. Days 1 – 5.

AST: Advanced solid tumors; C: Capecitabine; Gem: Gemcitabine; MTD: Maximum tolerated dose; NSCLC: Non-small cell lung cancer; ORR: Overall response rate;

P: Paclitaxel; PD: Progression of disease; S: Satraplatin; SD: Stable disease; Tax: Docetaxel.