Overview

Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone.

Status:
Not yet recruiting

Trial end date:
2023-04-24

Target enrollment:

Participant gender:

Summary

This is a phase 2 study conducted in two sequential stages: The first stage is an Italian single institution, single arm, pilot study, aimed at exploring the activity of the combination T and P in myxoid liposarcoma patients who achieved a stable disease after a minimum of 4 cycles of T alone. If a minimum required activity will be demonstrated from the first stage, the second stage of the study will be conducted;otherwise, the study will be stopped. The second stage is an Italian open-label, multicenter, randomized, double arm, phase II trial, aimed at evaluating the combination of T and P in myxoid liposarcoma and G1 or G2 dedifferentiated liposarcomas compared to the standard treatment with T alone. Patients will be randomized with a 1:1 ratio to treatments arms as specified below: - Control arm (A): T alone - Experimental arm (B): T in combination with P

Phase:

Phase 2

Details

Lead Sponsor:

Mario Negri Institute for Pharmacological Research

Collaborators:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Humanitas Hospital, Italy

Treatments:

Pioglitazone
Trabectedin