Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Who is this study for? Patients with Mesenchymal Chondrosarcoma
What treatments are being studied? Trabectedin
Status: Active, not recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: No
View:

• Age ≥ 16 years old

• Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion

• Locally advanced disease and/or metastatic disease

• Measurable or evaluable disease with RECIST v1.1

• Evidence of progression by RECIST v1.1 during the 6 months before study entry

• Patients must be pre-treated with at least one prior chemotherapy treatment containing anthracyclines for the advanced phase of disease and with a maximum of 3 lines

• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

• Adequate bone marrow function

• Adequate organ function

• Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy.

• Cardiac ejection fraction ≥50% as measured by echocardiogram

• No history of arterial and/or venous thromboembolic event within the previous 12 months

• The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.

• Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo
Fondazione IRCSS Istituto Nazionale dei Tumori
Milan
Ospedale Giaccone
Palermo
Nuovo Ospedale di Prato
Prato
Policlinico Universitario Campus Biomedico
Roma
Time Frame
Start Date: September 14, 2021
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 16
Treatments
Experimental: Trabectedin
Trabectedin: 1.5 mg/m² - 1.3 mg/m² (at investigator's discretion, with a top-dose of 2.6 total mg per cycle), given in 24-hour continuous infusion
Sponsors
Collaborators: PharmaMar
Leads: Italian Sarcoma Group

This content was sourced from clinicaltrials.gov

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