Status:
UNKNOWN
Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone.
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Humanitas Hospital, Italy
Conditions:
Liposarcoma, Myxoid
Liposarcoma, Dedifferentiated
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 my...
Detailed Description
In the specific the first stage will be an Italian mono-institutional, single arm, pilot study exploring the activity of the combination of T and P in myxoid liposarcoma patients who achieved a stable...
Eligibility Criteria
Inclusion
- 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
- Pregnant or breast-feeding women
- Partial response or progression disease as per RECIST criteria to the previous treatment with T
- 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
- Active major infection
- Other serious concomitant illnesses
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04794127
Start Date
February 2 2022
End Date
February 2 2025
Last Update
March 13 2024
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale Tumori
Milan, MI, Italy, 20133