Table 3 .

Clinical Trials With Lonidamine in Advanced Cancer

No. of
Patients	Patient Population	Study Design	Dose	Total Dose
31	Various solid tumors	Phase 1	180–520 mg/mg2/day	At least 28 days
			(∼306–884 mg/day*)
12	Various metastatic cancers	Phase 2, single-arm	270 mg/mg2/day (∼459 mg/day)	2200–76,800 mg
30	Various solid tumors	Phase 2, single-arm	Up to 450 mg/m2 (∼765 mg/day)	Median 180 days
64/60/60	Lung cancer	Randomized	600 mg/day	58 days
141/163	Lung cancer	Randomized	450 mg/day	Median 10 months
30/32/33	Elderly lung cancer	Randomized	450 mg/day	At least 8 weeks
104/103	Breast cancer	Randomized	600 mg/day (in combination	Median 126 days
			with epirubicin)
65/69	Breast cancer	Randomized	600 mg/day (in combination	Average 60 days
			with doxorubicin)
57/55	Breast cancer	Randomized	600 mg/day (in combination	Median 9 months
			with chemotherapy)
80/78	Lung cancer	Randomized	450 mg/day	Approximately 7 months
49/48	Head and neck cancer	Randomized	450 mg/day	8 months
152/158	Lung cancer	Randomized	265 mg/mg2/day (∼450 mg/day)	230 days
160/148	Breast cancer	Randomized	600 mg/day	Until progression about 9 months
128/126	Breast cancer	Randomized	600 mg/day	Until progression about 9 months

Sources of data: Young et al.²⁸, Band et al.²⁹.³⁰, Gatzemeier et al.³¹, Cionini²⁴, De Marinis et al.³², Dogliotti et al.²⁶, Amadori et al.³³, Gallo-Curcio et al.³⁴, Ianniello et al.¹⁸, Magno et al.³⁵, Scarantino et al.³⁶, Pacini et al.³⁷, Calabresi et al.²⁰