ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

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
Small Cell Lung Cancer Drug: Irinotecan liposome injection Drug: Topotecan 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. Approximately 24-36 patients will be 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 486 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 : April 25, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Experimental Arm
Irinotecan liposome injection
Drug: Irinotecan liposome injection
IV
Other Name: ONIVYDE®

Active Comparator: Control Arm
Topotecan
Drug: Topotecan
IV




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Able to understand and provide an informed consent
  • 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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088813


Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Show 25 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Medical Director Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03088813     History of Changes
Other Study ID Numbers: MM-398-01-03-04
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Camptothecin
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action