Actively Recruiting
Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
Led by Italian Sarcoma Group · Updated on 2026-03-27
16
Participants Needed
7
Research Sites
276 weeks
Total Duration
On this page
Sponsors
I
Italian Sarcoma Group
Lead Sponsor
P
PharmaMar
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, uncontrolled, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic)
CONDITIONS
Official Title
Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older
- Histological confirmation of skeletal or extra-skeletal mesenchymal chondrosarcoma with HEY1-NCOA2 fusion
- Locally advanced or metastatic disease
- Measurable or evaluable disease according to RECIST v1.1
- Disease progression within 6 months before study entry by RECIST v1.1
- Prior treatment with at least one anthracycline-based chemotherapy regimen for advanced disease (up to 3 lines)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate bone marrow function
- Adequate organ function
- Negative pregnancy test within 7 days before starting each chemotherapy cycle for women of childbearing potential
- Cardiac ejection fraction of 50% or higher by echocardiogram
- No arterial or venous thromboembolic events in the prior 12 months
- Ability to understand and provide written informed consent
- No other factors judged by the investigator to affect patient safety based on trabectedin safety data
You will not qualify if you...
- Other primary malignancy within the past 5 years, except certain low-risk cancers
- Radiation therapy within 14 days before first study drug dose or unresolved side effects from prior treatments
- Previous radiotherapy to 25% or more of bone marrow
- Major surgery within 2 weeks before study entry
- Participation in another clinical trial with investigational drugs within 4 weeks before treatment
- Persistent severe toxicities (grade 2 or higher) from prior anticancer therapies, except hair loss
- Pregnancy or breastfeeding
- Severe cardiac problems classified as grade III or IV by New York Heart Association criteria
- Arterial thrombotic or embolic events within 6 months before study treatment
- Known brain metastases
- Chronic liver disease such as active hepatitis or cirrhosis
- HIV infection
- Active or chronic hepatitis B or C requiring antiviral treatment
- Severe bleeding events (grade 3 or higher) within 4 weeks before study treatment
- Any serious or unstable illness or condition that could affect safety or study participation
- Known allergy to study drugs or their components
- Expected inability to comply with medical regimens during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Nuovo Ospedale di Prato
Prato, Firenze, Italy, 59100
Actively Recruiting
2
Policlinico Universitario Campus Biomedico
Roma, RM, Italy, 00128
Not Yet Recruiting
3
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy, 10060
Actively Recruiting
4
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
Actively Recruiting
5
Fondazione IRCSS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
6
Ospedale Giaccone
Palermo, Italy
Actively Recruiting
7
Istituti Fisioterapici Ospitalieri - Ospedale Regina Elena
Roma, Italy, 00128
Actively Recruiting
Research Team
S
Silvia Stacchiotti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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