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Topoisomerase I inhibitors
Lurbinectedin + Irinotecan for Cancer
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
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Who is the study for?
Adults with certain advanced solid tumors who've had a break from cancer treatments for at least three weeks, are in fairly good health (ECOG ≤ 1), and have a life expectancy of over three months. They must not be pregnant or breastfeeding and should use effective contraception. Excluded are those with active COVID-19, prior significant bone marrow treatments, known brain metastases, or allergies to study drugs.
What is being tested?
This is an early-phase trial testing the combination of two cancer drugs: Lurbinectedin and Irinotecan. It's divided into two parts: first finding the right doses (Phase I) and then expanding to more patients at that dose (Phase II).
What are the potential side effects?
Possible side effects include reactions related to drug infusion, fatigue, digestive issues like nausea and diarrhea, lowered blood cell counts leading to increased infection risk or bleeding problems, liver function changes, and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 66 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~66 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD)
Recommended Dose (RD)
Response Rate
Secondary study objectives
Area under the plasma concentration versus time curve (AUC)
Clearance (CL)
Duration of response
+7 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~2590
Lurbinectedin
FDA approved
Find a Location
Who is running the clinical trial?
PharmaMarLead Sponsor
91 Previous Clinical Trials
11,360 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other health conditions or diseases in addition to the one being studied.You have an extreme sensitivity or allergy to any of the study drugs or their ingredients.You have been treated with lurbinectedin, trabectedin (Yondelis®), or certain types of medications called topoisomerase I inhibitors (irinotecan, topotecan, etc.) in the past.You have cancer that has spread to your brain or the tissues surrounding your brain.You can have received any type of targeted therapy, hormonal therapy, or immunotherapy in the past.If you have glioblastoma, you must have finished radiation treatment at least 12 weeks ago, unless you have a new tumor outside the treated area or have had brain surgery to remove the tumor and the disease has been confirmed to be getting worse by examining the tissue.
Research Study Groups:
This trial has the following groups:- Group 1: Intermediate Escalation Group
- Group 2: Lurbinectedin Escalation Group
- Group 3: Irinotecan Escalation Group
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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