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New treatment option for Mesenchymal Chondrosarcoma
Official title Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
ClinicalTrials.gov ID: NCT04305548
What this study is testing
What is Trabectedin?
Trabectedin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mesenchymal chondrosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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
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...
- Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events...
- 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...
- Persistent toxicities (≥ grade 2) with the exception of alopecia, caused by previous anticancer therapies.
See the full eligibility criteria
- 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...
- Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data
- 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
- 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 (≥ 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
- 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
- Known brain metastasis
- Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)
- Known diagnosis oh 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 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...
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
- Expected non-compliance to medical regimens
The study team makes the final eligibility decision.
Where it's taking place
- Prato, Firenze, Italy
- Roma, RM, Italy
- Candiolo, Torino, Italy
- Bologna, Italy
- Milan, Italy
- Palermo, Italy
- Roma, Italy
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, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prato, Firenze, Italy; Roma, RM, Italy; Candiolo, Torino, Italy; Bologna, Italy; Milan, Italy; Palermo, Italy and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.