clinical trial · NCT02805725
Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide
Institut Bergonié·phase2·completed·n = 50
Soft-tissue SarcomasPhase 1: TrabectedinPhase 2: TrabectedinPhase 1: CyclophosphamidePhase 2: Cyclophosphamide
brief summary
Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).
started
Dec 1, 2015
primary completion
Apr 1, 2020
completion
Dec 1, 2021
last updated
Jan 14, 2026
detailed description
Phase I: Multicenter Phase I trial based on a dose escalation study design (3+3 traditional design). Phase II: One-arm, multicenter Phase II trial based on two-stage optimal Simon's design.
official title
Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (CP) in Patients With Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II Study From the French Sarcoma Group.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol