Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Trabectedin

    Drug

    Treatment with trabectedin: 1.5 mg/m² - 1.3 mg/m² (at investigator's discretion, with a top-dose of 2.6 total mg per cycle), given in 24-hour continuous infusion

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: TrabectedinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall tumour Response Rate, according to RECIST v 1.

Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
At weeks 6

Secondary outcomes

1

Choi criteria response rate

Response rate according Choi criteria

Time frame
At weeks 6, 12,18, 30, 42
2

Overall Survival

Proportion of patients who are still alive at 36 and 60 months after have started the treatment

Time frame
At 3 and 5 years
3

Progression Free Survival (PFS)

Survival without disease progression

Time frame
At 3 and 5 years
4

Clinical Benefit Rate

Proportion of patient alive, without disease progression, after 6 months of treatment.

Time frame
Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Sarcoma Group

Lead sponsor

PharmaMar

Collaborator

Source ClinicalTrials.gov
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