Phase II study on trabectedin in adults and young adults HEY1-NOCA2 positive skeletal and extra-skeletal mesenchymal chondrosarcoma (MCS)
- Conditions
- Advanced rearranged mesenchymal chondrosarcomaMedDRA version: 21.1Level: LLTClassification code: 10027389Term: Mesenchymal chondrosarcoma Class: 10029104MedDRA version: 27.0Level: LLTClassification code: 10027391Term: Mesenchymal chondrosarcoma metastatic Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-514319-85-00
- Lead Sponsor
- Italian Sarcoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Age = 16 years old, Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and thereafter, at the end of study treatment, for 3 months in female patients of childbearing potential and for 5 months in men in fertile age, 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 (ICF) 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., Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion (a paraffin embedded tumour block is required for centralized review), Locally advanced disease (i.e. surgical resection of local disease unfeasible radically or unaccepted by the patient or amenable to become less demolitive or feasible or easier after cytoreduction) 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 (Blood transfusions to reach the baseline requested Hb level are not allowed), Adequate organ function
Other primary malignancy with <5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse, Known brain metastasis, Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis), Known diagnosis of human deficiency virus (HIV) infection, Active or chronic hepatitis B or C requiring treatment with antiviral therapy, Medical history of hemorrhage or a bleeding event = Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment, Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results, Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs, Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data, Expected non-compliance to medical regimens, Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered, Previous radiotherapy to 25% of the bone marrow, Major surgery within 2 weeks prior to study entry, Participation in another clinical study with an investigational product, which last dose was taken less than 4 weeks prior to the start of the treatment., Persistent toxicities (= NCI CTCAE v5.0 grade 2) with the exception of alopecia, caused by previous anticancer therapies., Pregnancy or breast feeding, Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e. congestive heart failure, myocardial infarction within 6 months of study), Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method