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 monotherapy with trabectedin. - TRABEPIO

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 10 人开始时间: 2021年6月7日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•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

•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

发起方

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI