Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
Ipsen
Study ID
NCT03088813
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Apr 25, 2018
Status verified
Feb 2025
Primary completion
Feb 8, 2022
Completion
Jul 27, 2023

Study Design

Enrollment
491 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Experimental Arm, dose level 1
    Irinotecan liposome injection
  • Experimental: Part 1: Experimental Arm, dose level 2
    Irinotecan liposome injection
  • Experimental: Part 2: Experimental Arm
    Irinotecan liposome injection
  • Active Comparator: Part 2: Control Arm
    Topotecan

Primary Outcome Measure

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 680 days ]

Locations (22)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206-
Rocky Mountain Cancer CentersDenverColorado80218-
Florida Cancer Specialists (South Region)Fort MyersFlorida33916-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Northwest Georgia Oncology CentersMariettaGeorgia30060-
Cancer Treatment Centers of America-GeorgiaNewnanGeorgia30265-
Illinois Cancer Care, PCPeoriaIllinois61615-
Southern Maine Health CareBiddefordMaine04005-
University of Maryland Medical GroupBaltimoreMaryland21201-
Henry Ford HospitalDetroitMichigan48202-
Cancer & Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Sparrow Regional Cancer CenterLansingMichigan48219-
Roswell Park Cancer InstituteBuffaloNew York14263-
North Shore Hematology Oncology Associates, PCEast SetauketNew York11733-
Case Western Reserve UniversityClevelandOhio44106-
Tri County Hematology & Oncology Associates, IncMassillonOhio44646-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Charleston Hematology Oncology Associates, PACharlestonSouth Carolina29414-
Greenville Hospital System University Medical CenterGreenvilleSouth Carolina29605-
Tennessee OncologyNashvilleTennessee37203-
MultiCare Health System Institute for Research and InnovationSpokaneWashington99204-
Summit Cancer Treatment CenterSpokaneWashington99208-

Find similar trials in Denver, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
National Jewish Health· Denver, CORocky Mountain Cancer Centers· Denver, COFlorida Cancer Specialists (South Region)· Fort Myers, FLFlorida Cancer Specialists· St. Petersburg, FLNorthwest Georgia Oncology Centers· Marietta, GACancer Treatment Centers of America-Georgia· Newnan, GA

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