drugset / Trial / NCT02805725

Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide

NCT02805725

Phase 1/2 Completed 50 enrolled Institut Bergonié PharmaMar · collab
Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start
2015-12
Primary completion
2020-04
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg
Subject Trabectedin Small molecule 0.3 mg/m2 Intravenous
Subject Trabectedin Small molecule 0.4 mg/m2 Intravenous
Subject Trabectedin Small molecule 0.5 mg/m2 Intravenous
Subject Trabectedin Small molecule 0.6 mg/m2 Intravenous

Indications