RecruitingPhase 2

Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Italy16 participantsStarted 2021-09-14

Plain-language 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)

Who can participate

Age range16 Years

SexALL

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Inclusion 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

Exclusion criteria

✕. 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

What they're measuring

Overall tumour Response Rate, according to RECIST v 1.

Timeframe: At weeks 6

Trial details

NCT IDNCT04305548

SponsorItalian Sarcoma Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Silvia Stacchiotti, MD

39022390 silvia.stacchiotti@istitutotumori.mi.it

View on ClinicalTrials.gov More Mesenchymal Chondrosarcoma trials