WHO ICTRP trial

A Randomized & Observational phase II trial comparing the activity of…

CTIS2024-513820-40-00 · EU Clinical Trials Information System · Recruiting

Key facts

Trial ID CTIS2024-513820-40-00
Public title A Randomized & Observational phase II trial comparing the activity of TrabectedIn vs gemCitabine in patients with metastatic or locally advanced LEiomyosarcoma pretreated with conventional chemotherapy
Scientific title A Randomized & Observational phase II trial comparing the activity of TrabectedIn vs gemCitabine in patients with metastatic or locally advanced LEiomyosarcoma pretreated with conventional chemotherapy
Primary sponsor Italian Sarcoma Group
Registry EU Clinical Trials Information System
Recruitment status Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): Yes Therapeutic confirmatory - (Phase III): No Therapeutic use - (Phase IV): No
Countries Italy
Conditions Metastatic or locally advanced leiomyosarcoma MedDRA version: 21.1Level: PTClassification code: 10024189Term: Leiomyosarcoma Class: 100000004864 MedDRA version: 20.0Level: PTClassification code: 10024191Term: Leiomyosarcoma metastatic…
Interventions Product Name: Gemcitabina Accord 100 mg/ml concentrato per soluzione per infusione., Product Code:PRD3332928, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: Yondelis 0.25 mg powder for…
Registration date Apr 29, 2024
Target size 100
Secondary IDs NCT04383119;2020-000741-13
Registry page euclinicaltrials.eu

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