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Topoisomerase I inhibitors

Lurbinectedin for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by PharmaMar
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 66 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, Lurbinectedin, in combination with another cancer drug, irinotecan. The trial will have two parts: first, they will test different doses of the drugs to see what is safe; then, they will expand the trial to include more people.

Eligible Conditions
  • Advanced Solid Tumors
  • Neuroendocrine Tumors
  • Small Cell Lung Cancer
  • Stomach Cancer
  • Glioblastoma
  • Ovarian Cancer
  • Endometrial Cancer
  • Mesothelioma
  • Pancreatic Adenocarcinoma
  • Colorectal Cancer
  • Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~66 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 66 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Recommended Dose (RD)
Response Rate
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Clearance (CL)
Duration of response
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Lurbinectedin Escalation GroupExperimental Treatment2 Interventions
Irinotecan 75 mg/m^2 as a 90-min (-5-min/+30-min) intravenous (i.v.) infusion, followed by Lurbinectedin with starting dose of 1.0 mg/m^2 as a 60-min (-5-min/+20-min) i.v. infusion followed by Irinotecan alone on Day 8 (at the same dose as Day 1 and as a 90-min [-5-min/+30-min] i.v. infusion)
Group II: Irinotecan Escalation GroupExperimental Treatment2 Interventions
Starting dose of Irinotecan 15 mg/m^2 as a 90-min (-5-min/+30-min) i.v. infusion, followed by Lurbinectedin 3.0 mg/m^2 as a 60-min (-5-min/+20-min) i.v. infusion followed by Irinotecan alone on Day 8 (at the same dose as Day 1 and as a 90-min [-5-min/+30-min] i.v. infusion).
Group III: Intermediate Escalation GroupExperimental Treatment2 Interventions
Starting dose of Irinotecan 50 mg/m^2 as a 90-min (-5-min/+30-min) i.v. infusion, followed by Lurbinectedin 2.6 mg/m^2 as a 60-min (-5-min/+20-min) i.v. infusion. No Irinotecan dose will be administered on Day 8 in this group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Lurbinectedin
FDA approved

Find a Location

Who is running the clinical trial?

PharmaMarLead Sponsor
90 Previous Clinical Trials
11,330 Total Patients Enrolled

Media Library

Irinotecan (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT02611024 — Phase 1 & 2
Solid Tumors Research Study Groups: Intermediate Escalation Group, Lurbinectedin Escalation Group, Irinotecan Escalation Group
Solid Tumors Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT02611024 — Phase 1 & 2
Irinotecan (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02611024 — Phase 1 & 2

Frequently Asked Questions

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

Would it be possible to join this clinical trial?

"The data available on clinicaltrials.gov suggests that this trial is still enrolling patients. The original posting date was May 6th, 2016 and the most recent update was November 26th, 2021."

Answered by AI

What is the previous research on Lurbinectedin's efficacy?

"There are a total of 283 Lurbinectedin studies currently underway, 54 of which are Phase 3 trials. The majority of these active studies are based in Woolloongabba, Queensland; however, there are 8,831 clinical locations running these types of tests worldwide."

Answered by AI

What indications does Lurbinectedin commonly address?

"Lurbinectedin is a medication that oncologists often prescribe to patients with colorectal carcinoma. Additionally, it can be effective in treating ovarian cancer, sarcoma, and metastatic colorectal carcinoma."

Answered by AI

How many participants are needed for this clinical trial?

"That is correct. The online information on clinicaltrials.gov affirms that this study, which was first advertised on May 6th 2016, is recruiting patients at this time. They are currently looking for 320 individuals total from two different locations."

Answered by AI

Why did researchers design this clinical study in this way?

"As stated by the study's sponsor, PharmaMar, the primary goal of this trial is to establish the Maximum Tolerated Dose (MTD) over a 66-month period. Additionally, secondary objectives include evaluating antitumor response, half-life, and clearance."

Answered by AI
~36 spots leftby Apr 2025