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: 20.0 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: HLT Classification code 10024628 Term: Liposarcomas malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (in
Conditions
Interventions
Trade Name: Pioglitazone
Product Name: Pioglitazone
Product Code: [Pioglitazone]
Pharmaceutical Form: Tablet
INN or Proposed INN: PIOGLITAZONE
Current Sponsor code: NA
Concentration unit: mg milligram
Sponsors
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number and severity of Adverse Events according to NCI CTC v.5.0 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. | — |
Countries
Italy
Contacts
Public ContactLaboratorio di Metodologia per la R
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Outcome results
None listed