Clincosm LogoSign in Get a demo

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

Sponsor
Ipsen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03088813
Collaborator
(none)
480
Enrollment
118
Locations
2
Arms
55.2
Anticipated Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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:

  1. Dose determination of irinotecan liposome injection

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
RESILIENT: 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
Actual Study Start Date :
Apr 25, 2018
Actual Primary Completion Date :
Feb 8, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Arm

Irinotecan liposome injection

Drug: Irinotecan liposome injection
IV
Other Names:
  • ONIVYDE®

    		•
    Active Comparator: Control Arm

    Topotecan

    Drug: Topotecan
    IV

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [40 months]

      Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.

    Secondary Outcome Measures

    1. Progression-free survival [40 months]

      Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first

    2. Objective Response [40 months]

      Objective response is defined as the time from randomization to date of progression or death. Objective response rate (ORR) is the proportion of patients who achieve partial response or complete response according to RECIST v1.1 guidelines

    3. Quality of Life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-C30/LC13) dyspnea scale [Baseline to week 12]

    4. Quality of Life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) cough scale [Baseline to week 12]

    5. Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities [Enrollment to 30 days after permanent treatment termination]

      Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. Patients with asymptomatic CNS metastases prior to enrollment

    2. Prior radiation for CNS metastatic disease is completed ≥4 weeks prior to enrollment

    3. 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.

    4. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206
    2 Rocky Mountain Cancer Centers Denver Colorado United States 80218
    3 Florida Cancer Specialists (South Region) Fort Myers Florida United States 33916
    4 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    5 Northwest Georgia Oncology Centers Marietta Georgia United States 30060
    6 Cancer Treatment Centers of America-Georgia Newnan Georgia United States 30265
    7 Illinois Cancer Care, PC Peoria Illinois United States 61615
    8 Southern Maine Health Care Biddeford Maine United States 04005
    9 University of Maryland Medical Group Baltimore Maryland United States 21201
    10 Henry Ford Hospital Detroit Michigan United States 48202
    11 Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan United States 49503
    12 Sparrow Regional Cancer Center Lansing Michigan United States 48219
    13 Roswell Park Cancer Institute Buffalo New York United States 14263
    14 North Shore Hematology Oncology Associates, PC East Setauket New York United States 11733
    15 Case Western Reserve University Cleveland Ohio United States 44106
    16 Tri County Hematology & Oncology Associates, Inc Massillon Ohio United States 44646
    17 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    18 Charleston Hematology Oncology Associates, PA Charleston South Carolina United States 29414
    19 Greenville Hospital System University Medical Center Greenville South Carolina United States 29605
    20 Tennessee Oncology Nashville Tennessee United States 37203
    21 MultiCare Health System Institute for Research and Innovation Spokane Washington United States 99204
    22 Summit Cancer Treatment Center Spokane Washington United States 99208
    23 Border Medical Oncology Research Unit Albury New South Wales Australia 2640
    24 South West Healthcare Warrnambool Victoria Australia 3280
    25 Southern Medical Day Care Centre Wollongong Australia
    26 Princess Alexandra Hospital Woolloongabba Australia
    27 AZ Klina Brasschaat Belgium
    28 UZ Leuven Leuven Belgium
    29 Centre Hospitalier de l'Ardenne Libramont Belgium
    30 AZ Sint-Maarten Mechelen Belgium
    31 Hospital de Cancer de Barretos, Fundacoa Pio X II Barretos Brazil
    32 Hospital de Caridade de Ijuí Ijuí Brazil
    33 Oncobio Servicos de Saude Nova Lima Brazil
    34 HGB - Hospital Giovanni Battista - Mãe de Deus Center Porto Alegre Brazil
    35 Hospital Nossa Senhora da Conceição Porto Alegre Brazil
    36 INCA - Instituto Nacional de Câncer Rio De Janeiro Brazil
    37 CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Santo André Brazil
    38 Fundação Faculdade Regional de Medicina de São José do Rio Preto São José Do Rio Preto Brazil
    39 Beijing Cancer Hospital Beijing China 100142
    40 The First Affiliated Hospital of Bengbu Medical College Bengbu China 233004
    41 The First Hospital of Jilin University Changchun China 450008
    42 West China Hospital, Sichuan University Chengdu China 610041
    43 Guangdong Provincial People's Hospital Guangzhou China 510080
    44 Zhejiang Cancer Hospital Hangzhou China 310022
    45 Tongji Hospital Hubei China 430030
    46 Linyi Cancer Hospital Linyi China
    47 Henan Cancer Hospital Zhengzhou China
    48 CHU Brest - Hôpital Morvan Brest France
    49 Hôpital Nord - CHU Marseille Marseille France
    50 Institut de Cancérologie de la Loire Saint-Priest-en-Jarez France
    51 Centre Hospitalier de Saint-Quentin Saint-Quentin France 02321
    52 Universitaetsklinikum Freiburg Freiburg Germany 79106
    53 Evangelisches Krankenhaus Hamm GmbH Hamm Germany 50063
    54 Universitaetsklinikum Heidelberg Heidelberg Germany 69126
    55 Pius-Hospital Oldenburg Oldenburg Germany 26121
    56 Semmelweis Egyetem Budapest Hungary
    57 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza Gyula Hungary
    58 Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
    59 Tudogyogyintezet Torokbalint Törökbálint Hungary
    60 Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
    61 Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori Meldola Italy
    62 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy
    63 Azienda Sanitaria Universitaria Integrata di Udine Udine Italy
    64 Chungbuk National University Hospital Cheongju-si Korea, Republic of
    65 Asan Medical Center Seoul Korea, Republic of
    66 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of
    67 The Catholic University of Korea, St. Vincent's Hospital Suwon Korea, Republic of
    68 KO-MED Centra Kliniczne Biala Podlaska Biała Podlaska Poland
    69 Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością Gdynia Poland
    70 SP Zespol Gruzlicy i Chorob Pluc w Olsztynie Olsztyn Poland
    71 Przychodnia Med-Polonia Sp. z o.o. Poznań Poland
    72 Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego Poznań Poland
    73 S.C Gral Medical S.R.L Bucuresti Romania
    74 Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca Cluj-Napoca Romania
    75 S.C Medisprof S.R.L Cluj-Napoca Romania
    76 S.C Centrul de Oncologie Sf. Nectarie S.R.L Craiova Romania
    77 S.C Radiotherapy Center Cluj S.R.L Floreşti Romania
    78 Oncomed SRL Timişoara Romania
    79 SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" Arkhangel'sk Russian Federation
    80 "VitaMed" LLC Moscow Russian Federation
    81 BHI of Omsk region "Clinical Oncology Dispensary" Omsk Russian Federation
    82 SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary" Saint Petersburg Russian Federation 197022
    83 SPb SBIH "City Clinical Oncological Dispensary" Saint Petersburg Russian Federation
    84 SBIH of Yaroslavl region "Regional Clinical Oncological Hospital" Yaroslavl Russian Federation
    85 Clinical Center "Bezanijska kosa" Belgrade Serbia
    86 Oncomed System Belgrade Serbia
    87 Clinical Center Kragujevac Belgrad Serbia
    88 Institute for Pulmonary Diseases of Vojvodina Sremska Kamenica Serbia
    89 General Hospital Uzice Užice Serbia 31000
    90 ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet De Llobregat Barcelona Spain 08908
    91 Hospital General Universitario de Alicante Alicante Spain
    92 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    93 Hospital Universitario 12 de Octubre Madrid Spain 28041
    94 Hospital General Universitario Gregorio Marañon Madrid Spain
    95 Hospital Regional Universitario de Malaga Málaga Spain 29010
    96 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    97 Hospital Universitari i Politecnic La Fe Valencia Spain 46026
    98 Changhua Christian Hospital Changhua Taiwan
    99 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan
    100 National Taiwan University Hospital Taipei Taiwan 100
    101 Tri-Service General Hospital Taipei Taiwan
    102 Chang Gung Memorial Hospital, Linkou Taoyuan Taiwan 333
    103 Baskent University Adana Application and Research Center Adana Turkey
    104 Trakya University Medical Faculty Edirne Turkey
    105 Istanbul Medeniyet Uni Goztepe Training&Res Hosp Istanbul Turkey
    106 Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Istanbul Turkey
    107 Inonu Uni. Med. Fac. Malatya Turkey
    108 Namik Kemal University Tekirdağ Turkey
    109 CI Chernivtsi RC Oncological Dispensary Chernivtsi Ukraine
    110 CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU Dnipro Ukraine
    111 Communal Non-profit Enterprise Regional Center of Oncology Kharkiv Ukraine 61070
    112 Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council Kremenchuk Ukraine 39617
    113 CI Kryvyi Rih Oncological Dispensary of DRC Kryvyi Rih Ukraine
    114 Treatment-Prevention Institution Volyn Regional Oncological Dispensary Luts'k Ukraine
    115 Odesa Regional Oncologic Dispensary Odesa Ukraine
    116 RCI Sumy Regional Clinical Oncological Dispensary Sumy Ukraine
    117 CCCH City Oncological Center SHEI Uzhgorod NU Uzhgorod Ukraine 88000
    118 Medical Clinic Innovacia, LLC Vyshhorod Ukraine 07352

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT03088813
    Other Study ID Numbers:
    • MM-398-01-03-04
    • 2017-004261-26
    First Posted:
    Mar 23, 2017
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Irinotecan
    Topotecan

    Study Results

    No Results Posted as of Aug 10, 2022