Combining Trabectedin and Pioglitazone for Myxoid Liposarcoma Treatment

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)

This study is testing if combining two medications, trabectedin and pioglitazone, can help people with myxoid liposarcoma who have stable disease after using trabectedin alone.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mario Negri Institute for Pharmacological Research (other)
• Locations: 1 site (Milano, MI)
• Trial ID: NCT04794127 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial investigates the effectiveness of combining trabectedin (T) with pioglitazone (P) in patients with myxoid liposarcoma who have stable disease after receiving trabectedin alone. The study is conducted in two stages: the first is a pilot study at a single Italian institution to assess initial activity, while the second stage will be a multicenter, randomized trial comparing the combination treatment to trabectedin alone. Patients will be randomized in a 1:1 ratio to either continue with trabectedin or receive the combination treatment. The trial aims to recruit a total of 90 evaluable patients across multiple centers in Italy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of myxoid or dedifferentiated liposarcoma who have achieved stable disease after prior treatment with trabectedin.

Not a fit: Patients with progressive disease or partial response to previous trabectedin treatment, as well as those with inadequate organ function or other malignancies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with myxoid liposarcoma, potentially improving outcomes compared to standard treatment.

How similar studies have performed: While this approach is novel in the context of myxoid liposarcoma, similar combinations have shown promise in other cancer types, indicating potential for success.

Eligibility 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

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
9. Other serious concomitant illnesses

Where this trial is running

Milano, MI

• Fondazione IRCCS Istituto Nazionale Tumori — Milano, MI, Italy (RECRUITING)

Study contacts

• Study coordinator: Roberta Sanfilippo, MD

Conditions: Liposarcoma, Myxoid, Liposarcoma, Dedifferentiated, Liposarcoma, Round Cell, liposarcoma, trabectedin, pioglitazone