Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
ConditionMesenchymal Chondrosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorItalian Sarcoma Group
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Trabectedin
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Italian Sarcoma Group
Lead sponsor
PharmaMar
Collaborator
Source ClinicalTrials.gov