Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable… (NCT04794127) | Clinical Trial Compass
CompletedPhase 2
Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone.
Italy10 participantsStarted 2022-02-02
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Pregnant or breast-feeding women
✕. Partial response or progression disease as per RECIST criteria to the previous treatment with T
✕
What they're measuring
1
Objective response (OR) in patients with myxoid liposarcomas according to RECIST criteria or CHOI criteria
Timeframe: From the date of the enrollment up to 24 months
Trial details
NCT IDNCT04794127
SponsorMario Negri Institute for Pharmacological Research
. 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