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

NCT04794127 | Completed Phase 2 DMC

• 1 other identifier: IRFMN-SARCO-7953
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Liposarcoma, Myxoid; Liposarcoma, Dedifferentiated; Liposarcoma, Round Cell

Keywords

liposarcoma; trabectedin; pioglitazone

Outcome Measures

Primary Outcomes (1)

• Objective response (OR) in patients with myxoid liposarcomas according to RECIST criteria or CHOI criteria

  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.

  From the date of the enrollment up to 24 months

Secondary Outcomes (2)

• Number and severity of Adverse Events

  up to 24 months

• Maximum Plasma Concentration [Cmax]

  up to 24 months

Study Arms (1)

Trabectedin in combination with Pioglitazone

EXPERIMENTAL

Trabectedin administered at a dose of 1.5 mg/m2-1.3 mg/m2 (according to investigator's choice, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access every 3 weeks and Pioglitazone given continuously at the daily dose of 45 mg by oral route. Since Trabectedin has no cumulative toxicities, and Pioglitazone as well, the combination will be administered until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment, or medical decision by the responsible physician.

Drug: Trabectedin; Drug: Pioglitazone Oral Product

Interventions

Trabectedin DRUG

Patients will be treated with Trabectedin administered at a dose of 1.5 mg/m2-1.3 mg/m2 (according to investigator's choice, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access every 3 weeks and pioglitazone given continuously at the daily dose of 45 mg by oral route.

Also known as: Trabectedine

Trabectedin in combination with Pioglitazone

Pioglitazone Oral Product DRUG

Patients will be treated with Trabectedin administered at a dose of 1.5 mg/m2-1.3 mg/m2 (according to investigator's choice, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access every 3 weeks and pioglitazone given continuously at the daily dose of 45 mg by oral route.

Also known as: Pioglitazone

Trabectedin in combination with Pioglitazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of myxoid/round cell liposarcomas
• Histological diagnosis confirmation by a reference centre
• Age ≥ 18 years
• ECOG PS ≤2
• One or more previous systemic treatments employing anthracyclines +/- ifosfamide (unless one or both are clinically contraindicated)
• Four or more previous cycles of T with a stable disease as defined by RECIST criteria
• Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or higher
• Provision of signed informed consent

You may not qualify if:

• Pregnant or breast-feeding women
• Partial response or progression disease as per RECIST criteria to the previous treatment with T
• Inadequate haematological, renal and liver functions
• History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse
• Known central nervous system (CNS) metastases
• Active viral hepatitis or chronic liver disease
• Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
• Active major infection
• Other serious concomitant illnesses

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• Humanitas Hospital, Italy: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, MI, 20133, Italy

Location

MeSH Terms

Conditions

Liposarcoma, Myxoid; Liposarcoma

Interventions

Trabectedin; Pioglitazone

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Maurizio D'Incalci, MD

  Humanitas University

  STUDY CHAIR

• Irene De Simone

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II, pilot, open-label study

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 11, 2021
• Study Start: February 2, 2022
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)