A Randomized, Open Label Phase 3 Study of Irinotecan liposome injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy
Part 1a is an open –label safety run-in of irinotecan liposome injection for the purpose of establishing the dose of irinotecan liposome injection given every 2 weeks. Part 1b is a parallel study of irinotecan liposome injection and IV topotecan for the purpose of characterizing preliminary efficacy and safety or irinotecan liposome injection and IV topotecan. Part 2 is a randomized, efficacy study or irinotecan liposome injection versus IV topotecan.
Contact Candace LeBlanc 508-556-5431 or Marcy Kirkpatrick 508-556-5429 for more information.
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