Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05229588 | Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations | PHASE2 | COMPLETED | 8 | — | — | Jun 14, 2022 | Aug 4, 2025 | Aug 15, 2025 | 1 | United States |
To evaluate the antitumor activity of Lurbinectedin in terms of overall response rate (ORR), according to RECIST v.1.1, in patients with advanced pancreatic cancer with DNA repair mutations.
| Arm | Type | Description |
|---|---|---|
| Lurbinectedin | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Voluntary written informed consent form (ICF) of the patient obtained before any study-specific procedure. * Age ≥ 18 years of age; male or female. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤1 * Histologically or cytologically confirmed gastroin...