Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations
NCT05229588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-08-15
Summary
The purpose of this research is to evaluate the activity and safety of lurbinectedin in adult patients with advanced Gastrointestinal Malignancies with DNA repair mutations.
Conditions
Interventions
- DRUG
-
Lurbinectedin 4 MG Injection [Zepzelca]
Lurbinectedin will be administered with a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride). Lurbinectedin will be administered intravenously through peripheral or central lines at a dose of 3.2 mg/m2 at a fixed infusion rate.
Sponsors & Collaborators
- collaborator INDUSTRY
-
HonorHealth Research Institute
lead OTHER
Principal Investigators
-
Erkut Borazanci, MD · HonorHealth Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-14
- Primary Completion
- 2025-08-04
- Completion
- 2025-08-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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