NCT04794127CompletedPhase 2
Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone.
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)
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 3 Mar 2021
- Start date
- Feb 2022
- Primary completion date
- Sept 2024
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Diseases
- Sarcoma
- NCT number
- NCT04794127
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 10
- From Feb 2022 to the primary completion date, Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Partial response or progression disease as per RECIST criteria to the previous treatment with T
- Other serious concomitant illnesses
Other illness
- 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
- 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
- Pregnant or breast-feeding women
- Inadequate haematological, renal and liver functions
- Known central nervous system (CNS) metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.