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NCT03088813 · ClinicalTrials.gov registry record · Phase 3
Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
A Phase 3 study of Small-cell Lung Cancer, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 491
- Enrollment target
- 20
- Study locations
NCT03088813: Completed Phase 3 study of Small-cell Lung Cancer, sponsored by Ipsen.
NCT03088813 is a Phase 3 study of Small-cell Lung Cancer that has completed, run by Ipsen. The registered enrollment target is 491 participants, above the 226-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (117% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03088813, a Phase 3 study of Small-cell Lung Cancer, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 491 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 The study was conducted in two parts: 1. Dose determination of irinotecan liposome injection 2. A randomized, efficacy study of irinotecan liposome injection versus topotecan
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant following or during exposure to a study treatment, whether or not causally related to the study treatment. An undesirable medical condition could be symptoms, signs or abnormal results of an investigation. An SAE was any AE that: resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; resulted in congenit
Conditions Studied
Interventions
- DRUG Topotecan
- DRUG Irinotecan liposome injection
Study Locations (20)
Michigan
- Henry Ford Hospital - Detroit
- Cancer & Hematology Centers of Western Michigan - Grand Rapids
- Sparrow Regional Cancer Center - Lansing
Colorado
- National Jewish Health - Denver
- Rocky Mountain Cancer Centers - Denver
Florida
- Florida Cancer Specialists (South Region) - Fort Myers
- Florida Cancer Specialists - St. Petersburg
Georgia
- Northwest Georgia Oncology Centers - Marietta
- Cancer Treatment Centers of America-Georgia - Newnan
New York
- Roswell Park Cancer Institute - Buffalo
- North Shore Hematology Oncology Associates, PC - East Setauket
Ohio
- Case Western Reserve University - Cleveland
- Tri County Hematology & Oncology Associates, Inc - Massillon
South Carolina
- Charleston Hematology Oncology Associates, PA - Charleston
- Greenville Hospital System University Medical Center - Greenville
Illinois
- Illinois Cancer Care, PC - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2023-07-27 |
| Phase | Phase 3 |
What the finished NCT03088813 record still lists
NCT03088813 is an interventional study that assigns participants to a tested intervention. The registered 491 participants enrollment target is mid-sized for trials with a published cap, above the 226-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (117% higher).
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Topotecan is the first listed.
NCT03088813 names 20 study sites across 12 states, led by Michigan, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT03088813 about?
NCT03088813 is a clinical study titled "Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer". 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 The study was conducted in two parts: 1. Dose determination of irinotecan liposome injection...
What is the current status of trial NCT03088813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 491 participants. The study started on 2018-04-25. Estimated completion is 2023-07-27.
What conditions does trial NCT03088813 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT03088813?
The interventions under investigation include: Topotecan (DRUG), Irinotecan liposome injection (DRUG).
Who is sponsoring clinical trial NCT03088813?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03088813 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03088813's enrollment target sits among peer trials
491 11th of 79 higher than 69 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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