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Phase II study on trabectedin in adults and young adults HEY1-NOCA2 positive skeletal and extra-skeletal mesenchymal chondrosarcoma (MCS)
EU CTIS ID: 2024-514319-85-00
What this study is testing
The primary objective of this study is to explore the activity of trabectedin from 2nd to 4th line, in patients aged 16 years with advanced HEY1-NOCA2 positive MCS pre-treated with anthracycline-based chemotherapy. Therefore, with reference to a study population of patients with progressive by RECIST v1.1, locally advanced or metastatic, HEY1-NCOA2 positive MCS pre- treated with one, two or three lines of medical treatment, the primary end-point of the study will be to assess: Overall tumour Response Rate, according to RECIST v 1.1
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.