Table 1.

Phase I studies with trabectedin as single agent

First author	Type of tumor	Schedule	Doses	MTD	RD	DLTs
Forouzesh (2009)32	Solid tumors	4-weekly • 1-h weekly for 3 weeks • 3-h weekly for 3 weeks	0.46 to 0.80 mg/m2 0.30 to 0.65 mg/m2	0.70 mg/m2 0.65 mg/m2	0.61 mg/m2 0.58 mg/m2	Neutropenia Elevation of transaminases
Van Kesteren (2000)33	Solid tumors	3-weekly • 24-h infusion	0.05–1.8 mg/m2	1.8 mg/m2	1.5 mg/m2	Neutropenia Thrombocytopenia
Van Kesteren (2002)34	Solid tumors	3-weekly • 1-h infusion	0.05–1.1 mg/m2	1.8 mg/m2	1.5 mg/m2	Neutropenia Thrombocytopenia
Taamma (2001)35	Solid tumors	3-weekly • 24-h infusion	0.05–1.8 mg/m2	1.8 mg/m2	1.5 mg/m2	Neutropenia Thrombocytopenia
Ryan (2001)36	Solid tumors	3-weekly • 72-h infusion	0.06 to 1.2 mg/m2	1.2 mg/m2	1.05 mg/m2	Hematologic
Villalona-Calero (2002)37	Solid tumors	3-weekly • 1-h daily for 5 days	0.06 to 0.038 mg/m2/d	0.325 mg/m2/d	0.325 mg/m2/d	Neutropenia
Twelves (2003)38	Solid tumors	3-weekly • 1-h infusion • 3-h infusion	0.05 to 1.1 mg/m2	1.1 mg/m2 1.8 mg/m2	1.0 mg/m2 1.65 mg/m2	Neutropenia Thrombocytopenia Fatigue
Pardo (2012)39	Solid tumors	3-weekly • 3-h infusion	0.75 to 1.3 mg/m2	1.3 mg/m2	1.5 mg/m2	Neutropenia

Abbreviations: d, day; DLT, dose-limiting toxicity; h, hour; MTD, maximum tolerated dose; RD, recommended dose.