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)
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
Drug | Synonyms | Arms |
---|
Trabectedin | | Trabectedin |
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
Name | Type | Description | Interventions |
---|
Trabectedin | Experimental | 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 | |
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 first 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
June 16, 2021