Last updated on July 2020

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


Brief description of study

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 will be conducted in two parts:

  1. Dose determination of irinotecan liposome injection
  2. A randomized, efficacy study of irinotecan liposome injection versus topotecan

Detailed Study 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 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.

Clinical Study Identifier: NCT03088813

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National Jewish Health

Denver, CO United States
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Southern Maine Health Care

Biddeford, ME United States
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Maine Research Associates

Lewiston, ME United States
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Reliant Medical Group, Inc.

Worcester, MA United States
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Tennessee Oncology

Nashville, TN United States
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South West Healthcare

Warrnambool, Australia
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Asan Medical Center

Seoul, Korea, Republic of
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Catalan Institute of Oncology

L'Hospitalet De Llobregat, Spain
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"VitaMed" LLC

Moscow, Russian Federation
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Illinois Cancer Care, PC

Peoria, IL United States
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S.C Medisprof S.R.L

Cluj-Napoca, Romania
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Oncomed SRL

Timi?oara, Romania
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Sutter Cancer Center

Sacramento, CA United States
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Henry Ford Hospital

Detroit, MI United States
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Oncomed SRL

Timi?oara, Romania
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Oncomed SRL

Timi?oara, Romania
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Florida Cancer Specialists

Saint Petersburg, FL United States
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Florida Cancer Specialists

West Palm Beach, FL United States
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AZ Klina

Brasschaat, Belgium
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Oncomed SRL

Timi?oara, Romania
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UZ Leuven

Leuven, Belgium
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AZ Sint-Maarten

Mechelen, Belgium
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Oncomed SRL

Timişoara, Romania
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Xinmin

Guangzhou, China
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Recruitment Status: Open


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