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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: A Phase II Study on Trabectedin in Combination With PPARg Agonist Pioglitazone in Patients With Round Cell Myxoid Liposarcomas or Dedifferentiated G1 and G2 Liposarcomas With Stable Disease After a Mo

Brief 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

Detailed Summary:

In the specific the first stage will be an Italian mono-institutional, single arm, pilot study exploring the activity of the combination of 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 will be an Italian multicenter, open-label, 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.
Patients will be randomized by a centralized computer system with a 1:1 ratio to one of the following two arms:

  • Control arm (A): T alone
  • Experimental arm (B): T in combination with P The pilot study will be conducted in Italy at Istituto Nazionale Tumori Milano in order to recruit 10 evaluable patients.
    The second stage will be conducted in approximately 10 italian centers in order to recruit 80 evaluable patients.

Sponsor: Mario Negri Institute for Pharmacological Research

Current Primary Outcome: The primary activity endpoint is the number of responders.
Patients will be considered as responders if they reach a CR or PR as best response during treatment according to RECIST criteria or according to Choi criteria.

Original Primary Outcome: The primary activity endpoint is the number of responders.
Patients will be considered as responders if they reach a CR or PR as best response during treatment according to RECIST criteria or according to Choi criteria.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mario Negri Institute for Pharmacological Research

Dates:
Date Received: March 03, 2021
Date Started: February 02, 2022
Date Completion: February 02, 2024
Last Updated: October 24, 2023
Last Verified: October 01, 2023