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Alkylating agents

Lurbinectedin for Pancreatic Cancer

Phase 2
Recruiting
Led By Erkut Borazanci, MD
Research Sponsored by HonorHealth Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed gastrointestinal carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initiation of study treatment up to 2 years
Awards & highlights

Study Summary

This trial will test the effectiveness of lurbinectedin on patients with advanced pancreatic cancer who have DNA repair mutations.

Who is the study for?
Adults with advanced pancreatic cancer and specific DNA repair mutations who have had up to three prior chemotherapy treatments can join. They must have a measurable tumor, adequate organ function, and an ECOG performance status of ≤1. Pregnant or breastfeeding women, those with more than three chemo treatments, brain metastases, severe heart conditions, or active infections cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Lurbinectedin (Zepzelca), a drug given through injection for treating advanced pancreatic cancer in patients with certain DNA repair mutations. The goal is to see how well it works on tumors that haven't responded well to previous treatments.See study design
What are the potential side effects?
While not specified here, common side effects of Lurbinectedin may include fatigue, nausea, decreased appetite, diarrhea; blood cell count changes leading to increased risk of infection or bleeding; liver enzyme alterations; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer in the digestive system has been confirmed by lab tests.
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I can carry out all my self-care but cannot do heavy physical work.
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I haven't had chemotherapy, investigational drugs, or significant radiotherapy recently.
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My cancer cannot be removed by surgery and has spread.
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I have harmful mutations in specific genes related to DNA repair.
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My blood, liver, and kidney functions are within normal ranges.
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I have recovered from side effects of cancer treatment to mild symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of study treatment up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of study treatment up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the antitumor activity
Secondary outcome measures
Clinical benefit
Duration of response (DOR)
Measure amount of CA19-9, CEA, or CA125
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: LurbinectedinExperimental Treatment1 Intervention
Lurbinectedin will be administered intravenously (IV) as a 1-hour (±10 min) infusion on Day 1 of each cycle (one cycle = 3 weeks ± 48 hours).

Find a Location

Who is running the clinical trial?

HonorHealth Research InstituteLead Sponsor
25 Previous Clinical Trials
887 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,266 Total Patients Enrolled
Erkut Borazanci, MDPrincipal InvestigatorHonorHealth Research Institute
7 Previous Clinical Trials
384 Total Patients Enrolled

Media Library

Lurbinectedin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05229588 — Phase 2
Gastrointestinal Cancer Research Study Groups: Lurbinectedin
Gastrointestinal Cancer Clinical Trial 2023: Lurbinectedin Highlights & Side Effects. Trial Name: NCT05229588 — Phase 2
Lurbinectedin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05229588 — Phase 2

Frequently Asked Questions

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

Are there any possible dangers associated with Lurbinectedin 4 MG Injection [Zepzelca]?

"Lurbinectedin 4 MG Injection [Zepzelca] has been given a score of 2. This is because, while Phase 2 trials offer some evidence of safety, there is no data supporting efficacy."

Answered by AI

How many people suffering from this disease will be given the chance to test this new treatment?

"Yes, if you consult clinicaltrials.gov you will see that this study is still looking for test subjects. The trial was first announced on June 14th, 2022 and the most recent update was on August 8th of the same year. They are only recruiting 19 patients from a single location at this time."

Answered by AI

How can people sign up for this research project?

"That is accurate. The clinical trial is currently recruiting patients, with the latest update on 8/8/2022. Per the information available, 1 site will be enrolling 19 people in total."

Answered by AI

Who else is applying?

What state do they live in?
Idaho
How old are they?
18 - 65
What site did they apply to?
HonorHealth Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations
2022. "Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05229588.
~8 spots leftby Aug 2025
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