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Topoisomerase I inhibitor

Irinotecan liposome injection for Small Cell Lung Cancer (RESILIENT Trial)

Phase 3

Waitlist Available

Research Sponsored by Ipsen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) until death. assessed up to part 1 dco date of 11 august 2021 (approximately 1177 days)

Awards & highlights

RESILIENT Trial Summary

This trial is being done to study the safety and effectiveness of a new cancer drug, irinotecan liposome injection, compared to the standard drug, topotecan.

Eligible Conditions

Small Cell Lung Cancer

RESILIENT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) until death. assessed up to part 1 dco date of 11 august 2021 (approximately 1177 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) until death. assessed up to part 1 dco date of 11 august 2021 (approximately 1177 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) until death. assessed up to part 1 dco date of 11 august 2021 (approximately 1177 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)

Part 2: Overall Survival (OS)

Secondary outcome measures

Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12

Part 1: OS

+6 more

Side effects data

From 2023 Phase 3 trial • 491 Patients • NCT03088813

88%

Diarrhoea

44%

Nausea

40%

Asthenia

40%

Decreased appetite

36%

Weight decreased

36%

Hypomagnesaemia

36%

Vomiting

32%

Back pain

28%

Hypokalaemia

28%

Anaemia

20%

Abdominal pain

20%

Abdominal pain upper

20%

Alanine aminotransferase increased

16%

Thrombocytopenia

16%

Neutropenia

16%

Gamma-glutamyltransferase increased

16%

Fatigue

16%

Dizziness

16%

Dyspnoea

12%

Renal failure

12%

Dehydration

12%

Non-cardiac chest pain

12%

Urinary tract infection

12%

Pyrexia

12%

Hyperglycaemia

12%

Cough

12%

Aspartate aminotransferase increased

12%

Blood alkaline phosphatase increased

12%

Hypotension

12%

Dysphagia

Upper respiratory tract infection

Headache

Hyponatraemia

Pulmonary embolism

Deep vein thrombosis

Atrial fibrillation

Visual impairment

Oedema peripheral

Stomatitis

Abdominal sepsis

Pneumonia

Somnolence

Constipation

Hypocalcaemia

Arthralgia

Blood lactate dehydrogenase increased

Embolism arterial

Lymphopenia

Cardiac tamponade

Liver disorder

Hyperkalaemia

Hepatic failure

Pericardial effusion

Oesophageal stenosis

Erythema

Herpes zoster

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Irinotecan Liposome Injection 70 mg/m^2

Part 2: Irinotecan Liposome Injection 70 mg/m^2

Part 1: Irinotecan Liposome Injection 85 mg/m^2

Part 2: Topotecan 1.5 mg/m^2

RESILIENT Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: Experimental ArmExperimental Treatment1 Intervention

Irinotecan liposome injection

Group II: Part 1: Experimental Arm, dose level 2Experimental Treatment1 Intervention

Irinotecan liposome injection

Group III: Part 1: Experimental Arm, dose level 1Experimental Treatment1 Intervention

Irinotecan liposome injection

Group IV: Part 2: Control ArmActive Control1 Intervention

Topotecan

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan liposome injection

2018

Completed Phase 3

~500

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor

345 Previous Clinical Trials

72,737 Total Patients Enrolled

Ipsen Medical DirectorStudy DirectorIpsen

257 Previous Clinical Trials

54,654 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can join this research project?

"As of 8/9/2022, this trial is not recruiting patients. It was originally posted on 4/25/2018. If you are interested in other trials, 1606 are actively recruiting patients with small cell lung carcinoma and 328 for Irinotecan liposome injection."

Answered by AI

Are new enrollees still being taken for this experiment?

"The trial you are inquiring about is not recruiting patients at this moment. The study was first posted on April 25th, 2018 and updated last on August 9th, 2022. However, there are 1606 other trials for small cell lung carcinoma and 328 for Irinotecan liposome injection that are looking for participants."

Answered by AI

What is the standard protocol for Irinotecan liposome injection?

"Irinotecan liposome injection is the standard of care for leukemia, myelocytic, acute. This medication can also be used off-label to treat other conditions such as colorectal carcinoma, ovarian cancer, and sarcoma."

Answered by AI

Is this treatment unique to Irinotecan liposome injection?

"Currently, there are 328 active clinical trials for Irinotecan liposome injection and 68 of them are in Phase 3. While a few of these trials are based in Woolloongabba, Queensland, there are 11,297 total locations for these trials."

Answered by AI