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Trial intelligence / Profile preview
COOL Study
NCT05927857Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2024
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- National Health Research Institutes
- Modality
- Antibody Conjugates, Monoclonal Antibodies, Lipid-based Nanoparticles
- Conditions
- gastric adenocarcinoma
01
Overview
Phase 2, open-label, single-arm trial of nanoliposomal irinotecan, ramucirumab and trifluridine + tipiracil in gastric adenocarcinoma, sponsored by National Health Research Institutes. Primary endpoints: Maximum Tolerated Dose at 28 days and Objective Response Rate up to 24 months. Started Apr 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Phase 1b/II
nal-IRI + Ramucirumab + Trifluridine/Tipiracil
03
Who it enrols
Adult patients (20-80 years) with metastatic gastric adenocarcinoma who have received only one prior line of systemic therapy, with ECOG PS 0-1, adequate organ function, and no prior exposure to the study drugs.
04
Endpoints
Primary
Maximum Tolerated Dose
Objective Response Rate
Secondary
Disease Control Rate
Progression-Free Survival
Overall Survival
Safety Profile
Blood biomarkers
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