A PHASE II CLINICAL STUDY, ON TRABECTEDIN IN COMBINATION WITH PPARg AGONIST PIOGLITAZONE IN PATIENTS WITH ROUND CELL MYXOID LIPOSARCOMAS OR DEDIFFERENTIATED G1 OR G2 LIPOSARCOMAS WITH STABLE DISEASE IN TREATMENT WITH TRABECTEDIN ALONE.

Phase 1

• Conditions: Patients with myxoid/round cell liposarcoma treated with at least 4 cycle of T alone with a stable disease at the last tumor evaluation; MedDRA version: 20.0Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: HLTClassification code 10024628Term: Liposarcomas malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10073139Term: Round cell liposarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10073137Term: Myxoid liposarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005626-29-IT
• Lead Sponsor: IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1.Diagnosis of myxoid/round cell liposarcomas
2.Histological diagnosis confirmation by a reference centre
3.Age = 18 years
4.ECOG PS =2
5.One or more previous systemic treatments employing anthracyclines +/- ifosfamide (unless one or both are clinically contraindicated)
6.Four or more previous cycles of T with a stable disease as defined by RECIST criteria
7.Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or higher
8.Provision of signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1.Pregnant or breast-feeding women
2.Partial response or progression disease as per RECIST criteria to the previous treatment with T
3.Inadequate haematological, renal and liver functions
4.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
5.Known central nervous system (CNS) metastases
6.Active viral hepatitis or chronic liver disease
7.Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial
hypertension or arrhythmias
8.Active major infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is aimed at assessing the activity of T in combination with P in patients diagnosed with round cell myxoid liposarcomas or dedifferentiated G1 and G2 liposarcomas with stable disease after 4 cycles of treatment with T administered in monotherapy.;Secondary Objective: Secondary objectives will be to describe the efficacy and the safety of the combination treatment with T and P.;Primary end point(s): Objective response (OR) according to RECIST criteria or CHOI criteria;Timepoint(s) of evaluation of this end point: The objective response (CR or PR) according to RECIST v. 1.1 or CHOI criteria will be evaluated during the treatment until disease progression, consent withdrawal, lost to follow-up, death.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Number and severity of Adverse Events according to NCI CTC v.5.0<br>2. Pharmacokinetics parameters;Timepoint(s) of evaluation of this end point: The detection time will be calculated for the patients who will not experience serious adverse events and who maintain stable pharmacokinetic parameters during the study.