Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations

Conditions

• Gastrointestinal Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lurbinectedin 4 MG Injection [Zepzelca] — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jun 14, 2022

Status verified

Aug 2025

Primary completion

Aug 4, 2025

Completion

Aug 4, 2025

Study Design

Enrollment

8 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lurbinectedin
  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).

Primary Outcome Measure

Evaluate the antitumor activity [ Time Frame: Initiation of study treatment up to 10 cycles (each cycle is 21 days ± 48 hours) ]

Locations (1)

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