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

Soft-tissue Sarcomas Clinical Trial

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.

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02805725
Study type	Interventional
Source	Institut Bergonié
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 2015
Completion date	December 2021

View Details

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT02789384` - CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.	N/A
	Not yet recruiting	`NCT06308419` - A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions	Phase 1