Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 482
Summary
- Conditions
- Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Masking Description: Open LabelPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will be conducted in two parts: Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were enrolled. Part 1 Primary Objectives: Describe the safety and tolerability of irinotecan liposome injection monotherapy administered every 2 weeks Determine the optimal i...
The study will be conducted in two parts: Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were enrolled. Part 1 Primary Objectives: Describe the safety and tolerability of irinotecan liposome injection monotherapy administered every 2 weeks Determine the optimal irinotecan liposome injection monotherapy dose for Part 2 of this study Part 2: A randomized, efficacy study of irinotecan liposome injection versus IV topotecan. Approximately 450 patients will be enrolled in part 2. Part 2 objectives: Detailed in the Primary & Secondary outcome measure sections.
Tracking Information
- NCT #
- NCT03088813
- Collaborators
- Not Provided
- Investigators
- Study Director: Ipsen Medical Director Ipsen
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