Clinical Trials /

Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

NCT04305548

Description:

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)

Related Conditions:
  • Mesenchymal Chondrosarcoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
  • Official Title: Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Clinical Trial IDs

  • ORG STUDY ID: ISG-MCS
  • NCT ID: NCT04305548

Conditions

  • Mesenchymal Chondrosarcoma

Interventions

DrugSynonymsArms
TrabectedinTrabectedin

Purpose

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)

Detailed Description

      Prospective, uncontrolled, multicenter, Italian, 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), HEY1-NCOA2 positive MCS) ,
      pre-treated with anthracycline-based chemotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
TrabectedinExperimentalTrabectedin: 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
  • Trabectedin

Eligibility Criteria

        Inclusion Criteria:

          1. Age ≥ 16 years old

          2. Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the
             documented presence of HEY1-NCOA2 fusion

          3. Locally advanced disease and/or metastatic disease

          4. Measurable or evaluable disease with RECIST v1.1

          5. Evidence of progression by RECIST v1.1 during the 6 months before study entry

          6. 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

          7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

          8. Adequate bone marrow function

          9. Adequate organ function

         10. Female patients of childbearing potential must have negative pregnancy test within 7
             days before initiation each cycle of chemotherapy.

         11. Cardiac ejection fraction ≥50% as measured by echocardiogram

         12. No history of arterial and/or venous thromboembolic event within the previous 12
             months

         13. 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 study-specific procedures, including
             screening evaluations, sampling, and analyses.

         14. Any other factors, that, at judgment of investigator, could affect the safety of the
             patients according to the available trabectedin safety data

        Exclusion Criteria:

          1. 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

          2. 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

          3. Previous radiotherapy to 25% of the bone marrow

          4. Major surgery within 2 weeks prior to study entry

          5. 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.

          6. Persistent toxicities (≥ grade 2) with the exception of alopecia, caused by previous
             anticancer therapies.

          7. Pregnancy or breast feeding

          8. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria

          9. 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

         10. Known brain metastasis

         11. Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)

         12. Known diagnosis oh human deficiency virus (HIV) infection

         13. Active or chronic hepatitis B or C requiring treatment with antiviral therapy

         14. Medical history of hemorrhage or a bleeding event ≥ Grade 3 within 4 weeks prior to
             the initiation of study treatment

         15. 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

         16. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in
             the formulation of the study drugs

         17. Expected non-compliance to medical regimens
      
Maximum Eligible Age:N/A
Minimum Eligible Age:16 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall tumour Response Rate, according to RECIST v 1.
Time Frame:At weeks 6
Safety Issue:
Description:Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Secondary Outcome Measures

Measure:Choi criteria response rate
Time Frame:At weeks 6, 12,18, 30, 42
Safety Issue:
Description:Response rate according Choi criteria
Measure:Overall Survival
Time Frame:At 3 and 5 years
Safety Issue:
Description:Proportion of patients who are still alive at 36 and 60 months after have started the treatment
Measure:Progression Free Survival (PFS)
Time Frame:At 3 and 5 years
Safety Issue:
Description:Survival without disease progression
Measure:Clinical Benefit Rate
Time Frame:Month 6
Safety Issue:
Description:Proportion of patient alive, without disease progression, after 6 months of treatment.
Measure:Duration of response
Time Frame:At weeks 6, 12,18, 30, 42
Safety Issue:
Description:Duration of time between the date of first documented response and the date of first documented progression or death due to any cause
Measure:Adverse events related to the treatment
Time Frame:Week 3, week 6, week 9, week 12, week 18, week 24, week 36, week 48, week 60, week 72
Safety Issue:
Description:Safety in term of grading of adverse event is evaluate from the firs treatment dose throughout the study according to CTCAE 5.0

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Italian Sarcoma Group

Last Updated

March 11, 2020