Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of the combination as the recommended dose for phase II trial [Phase I]; objective response rate of the combination [Phase II]; toxicity and safety profile of the combination [Phase II]
Limiting tolerated dose (Phase I); efficacy/toxicity after the inclusion of the last patient (Phase II)
Yes
Armando Santoro, MD
Principal Investigator
Istituto Clinico Humanitas
Italy: Ministry of Health
ONC-2007-002
NCT00697476
January 2009
January 2010
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