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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088813
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE March 9, 2017
First Posted Date  ICMJE March 23, 2017
Last Update Posted Date August 28, 2020
Actual Study Start Date  ICMJE April 25, 2018
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
Overall survival (OS) [ Time Frame: 40 months ]
Overall survival is defined as the time from randomization to date of death. The primary hypothesis will test whether OS is increased in patients treated with irinotecan liposome injection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
  • Progression-free survival [ Time Frame: 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
  • Objective Response [ Time Frame: 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
  • Proportion of Patients with Symptom Improvement [ Time Frame: Randomization to 30 Days after permanent treatment termination ]
    Patient-reported EORTC-QLQ symptom scales for cough, dyspnea, and fatigue
  • Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
Official Title  ICMJE 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
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
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: Detailed in the Primary & Secondary outcome measure sections.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Irinotecan liposome injection
    IV
    Other Name: ONIVYDE®
  • Drug: Topotecan
    IV
Study Arms  ICMJE
  • Experimental: Experimental Arm
    Irinotecan liposome injection
    Intervention: Drug: Irinotecan liposome injection
  • Active Comparator: Control Arm
    Topotecan
    Intervention: Drug: Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2019)
480
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2017)
482
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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), immunotherapy, or chemo-radiation including platinum-based chemotherapy for treatment of limited or extensive stage Small Cell Lung Cancer (SCLC).
  • 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).
  • Adequate bone marrow reserves
  • Adequate hepatic function Adequate renal function
  • Electrocardiogram during the Screening period without any clinically significant findings, per investigator's assessment

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 e 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   China,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03088813
Other Study ID Numbers  ICMJE MM-398-01-03-04
2017-004261-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP