Lung Cancer Clinical Trial

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

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 will be conducted in two parts:

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

View Full Description

Full 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: To compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with intravenous (IV) topotecan.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age.
Able to understand and provide an informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy >12 weeks
Histopathologically or cytologically confirmed small cell lung cancer
Evaluable disease as defined by RECIST Version 1.1 guidelines (patients with non measurable lesions only are eligible).
Radiologically confirmed progression on or after first-line platinum based chemotherapy (carboplatin or cisplatin), or chemo-radiation including platinum-based chemotherapy for treatment of limited or extensive stage Small Cell Lung Cancer (SCLC). In addition to platinum-based regimen, one line of immunotherapy as monotherapy or in combination, in first or in second line setting is allowed.
Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to Grade 1 or better, with the exception of alopecia, peripheral neuropathy, or ototoxicity).
Adequate bone marrow reserves
Adequate hepatic function
Adequate renal function
Electrocardiogram during the Screening period without any clinically significant findings, per investigator's assessment

Patients with certain types of asymptomatic CNS metastases that meet ALL the following criteria are eligible.

Patients with asymptomatic CNS metastases prior to enrollment
Prior radiation for CNS metastatic disease is completed ≥4 weeks prior to enrollment
CNS metastases that are stable or have decreased according to the post radiation follow-up scan that is conducted at least 4 weeks after completion of radiation treatment for CNS lesion.
Patients have discontinued corticosteroids or are on stable low-dose steroids (prednisone or equivalent 10 mg daily or less) for at least 1 week after completion of radiation for CNS lesion prior to enrollment.

Exclusion Criteria

Any medical or social condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Pregnant or breast feeding;
Patients with large cell neuroendocrine lung carcinoma.
Patients who have received prior topoisomerase I inhibitor treatment, retreatment with platinum-based regimen, antibody-drug conjugates or molecular targeted agents, more than one line of immunotherapy, or any other additional regimen of prior cytotoxic chemotherapy.
Patients with the symptomatic Central Nervous System (CNS) metastasis and/or who have developed new or progressive brain metastasis within 3 months following prophylactic and/or therapeutic cranial radiation (whole brain stereotactic radiation).
Patients with carcinomatous meningitis.
Unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving the first dose of irinotecan liposome injection.
Have a previous or concurrent cancer that is distinct in primary (non-pulmonary) site or SCLC histology
Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is less, prior to the first scheduled day of dosing in this study.
Severe cardiovascular and pulmonary diseases
New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled blood pressure.
Active infection
Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or topotecan.
Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

480

Study ID:

NCT03088813

Recruitment Status:

Active, not recruiting

Sponsor:

Ipsen

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There are 50 Locations for this study

See Locations Near You

National Jewish Health
Denver Colorado, 80206, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
Florida Cancer Specialists (South Region)
Fort Myers Florida, 33916, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Northwest Georgia Oncology Centers
Marietta Georgia, 30060, United States
Cancer Treatment Centers of America-Georgia
Newnan Georgia, 30265, United States
Illinois Cancer Care, PC
Peoria Illinois, 61615, United States
Southern Maine Health Care
Biddeford Maine, 04005, United States
University of Maryland Medical Group
Baltimore Maryland, 21201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids Michigan, 49503, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48219, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
North Shore Hematology Oncology Associates, PC
East Setauket New York, 11733, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
Tri County Hematology & Oncology Associates, Inc
Massillon Ohio, 44646, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Charleston Hematology Oncology Associates, PA
Charleston South Carolina, 29414, United States
Greenville Hospital System University Medical Center
Greenville South Carolina, 29605, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
MultiCare Health System Institute for Research and Innovation
Spokane Washington, 99204, United States
Summit Cancer Treatment Center
Spokane Washington, 99208, United States
Border Medical Oncology Research Unit
Albury New South Wales, 2640, Australia
South West Healthcare
Warrnambool Victoria, 3280, Australia
Southern Medical Day Care Centre
Wollongong , , Australia
Princess Alexandra Hospital
Woolloongabba , , Australia
AZ Klina
Brasschaat , , Belgium
UZ Leuven
Leuven , , Belgium
Centre Hospitalier de l'Ardenne
Libramont , , Belgium
AZ Sint-Maarten
Mechelen , , Belgium
Hospital de Cancer de Barretos, Fundacoa Pio X II
Barretos , , Brazil
Hospital de Caridade de Ijuí
Ijuí , , Brazil
Oncobio Servicos de Saude
Nova Lima , , Brazil
HGB - Hospital Giovanni Battista - Mãe de Deus Center
Porto Alegre , , Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre , , Brazil
INCA - Instituto Nacional de Câncer
Rio De Janeiro , , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André , , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José Do Rio Preto , , Brazil
Beijing Cancer Hospital
Beijing , 10014, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu , 23300, China
The First Hospital of Jilin University
Changchun , 45000, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Guangdong Provincial People's Hospital
Guangzhou , 51008, China
Zhejiang Cancer Hospital
Hangzhou , 31002, China
Tongji Hospital
Hubei , 43003, China
Linyi Cancer Hospital
Linyi , , China
Henan Cancer Hospital
Zhengzhou , , China
CHU Brest - Hôpital Morvan
Brest , , France
Hôpital Nord - CHU Marseille
Marseille , , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez , , France
Centre Hospitalier de Saint-Quentin
Saint-Quentin , 02321, France
Universitaetsklinikum Freiburg
Freiburg , 79106, Germany
Evangelisches Krankenhaus Hamm GmbH
Hamm , 50063, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69126, Germany
Pius-Hospital Oldenburg
Oldenburg , 26121, Germany
Semmelweis Egyetem
Budapest , , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula , , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok , , Hungary
Tudogyogyintezet Torokbalint
Törökbálint , , Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg , , Hungary
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola , , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , , Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine , , Italy
Chungbuk National University Hospital
Cheongju-si , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
Suwon , , Korea, Republic of
KO-MED Centra Kliniczne Biala Podlaska
Biała Podlaska , , Poland
Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością
Gdynia , , Poland
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
Olsztyn , , Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznań , , Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznań , , Poland
S.C Gral Medical S.R.L
Bucuresti , , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca , , Romania
S.C Medisprof S.R.L
Cluj-Napoca , , Romania
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova , , Romania
S.C Radiotherapy Center Cluj S.R.L
Floreşti , , Romania
Oncomed SRL
Timişoara , , Romania
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangel'sk , , Russian Federation
"VitaMed" LLC
Moscow , , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk , , Russian Federation
SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"
Saint Petersburg , 19702, Russian Federation
SPb SBIH "City Clinical Oncological Dispensary"
Saint Petersburg , , Russian Federation
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl , , Russian Federation
Clinical Center "Bezanijska kosa"
Belgrade , , Serbia
Oncomed System
Belgrade , , Serbia
Clinical Center Kragujevac
Belgrad , , Serbia
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica , , Serbia
General Hospital Uzice
Užice , 31000, Serbia
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital General Universitario de Alicante
Alicante , , Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital General Universitario Gregorio Marañon
Madrid , , Spain
Hospital Regional Universitario de Malaga
Málaga , 29010, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain
Changhua Christian Hospital
Changhua , , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , , Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Tri-Service General Hospital
Taipei , , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan , 333, Taiwan
Baskent University Adana Application and Research Center
Adana , , Turkey
Trakya University Medical Faculty
Edirne , , Turkey
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul , , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul , , Turkey
Inonu Uni. Med. Fac.
Malatya , , Turkey
Namik Kemal University
Tekirdağ , , Turkey
CI Chernivtsi RC Oncological Dispensary
Chernivtsi , , Ukraine
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipro , , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv , 61070, Ukraine
Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council
Kremenchuk , 39617, Ukraine
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih , , Ukraine
Treatment-Prevention Institution Volyn Regional Oncological Dispensary
Luts'k , , Ukraine
Odesa Regional Oncologic Dispensary
Odesa , , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary
Sumy , , Ukraine
CCCH City Oncological Center SHEI Uzhgorod NU
Uzhgorod , 88000, Ukraine
Medical Clinic Innovacia, LLC
Vyshhorod , 07352, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

480

Study ID:

NCT03088813

Recruitment Status:

Active, not recruiting

Sponsor:


Ipsen

How clear is this clinincal trial information?

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