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Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma (ISG-MCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04305548
Recruitment Status : Not yet recruiting
First Posted : March 12, 2020
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Italian Sarcoma Group

Brief 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)

Condition or disease Intervention/treatment Phase
Mesenchymal Chondrosarcoma Drug: Trabectedin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Trabectedin

Arm Intervention/treatment
Experimental: Trabectedin
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
Drug: Trabectedin
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




Primary Outcome Measures :
  1. Overall tumour Response Rate, according to RECIST v 1. [ Time Frame: At weeks 6 ]
    Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1


Secondary Outcome Measures :
  1. Choi criteria response rate [ Time Frame: At weeks 6, 12,18, 30, 42 ]
    Response rate according Choi criteria

  2. Overall Survival [ Time Frame: At 3 and 5 years ]
    Proportion of patients who are still alive at 36 and 60 months after have started the treatment

  3. Progression Free Survival (PFS) [ Time Frame: At 3 and 5 years ]
    Survival without disease progression

  4. Clinical Benefit Rate [ Time Frame: Month 6 ]
    Proportion of patient alive, without disease progression, after 6 months of treatment.

  5. Duration of response [ Time Frame: At weeks 6, 12,18, 30, 42 ]
    Duration of time between the date of first documented response and the date of first documented progression or death due to any cause

  6. 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 in term of grading of adverse event is evaluate from the firs treatment dose throughout the study according to CTCAE 5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305548


Contacts
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Contact: Silvia Stacchiotti, MD 39022390 ext 2804 silvia.stacchiotti@istitutotumori.mi.it

Locations
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Italy
Nuovo Ospedale di Prato
Prato, Firenze, Italy, 59100
Contact: Giacomo G. Baldi, MD    0039057443 ext 4766    giacomogiulio.baldi@uslcentro.toscana.it   
Principal Investigator: Giacomo G. Baldi, MD         
Policlinico Universitario Campus Biomedico
Roma, RM, Italy, 00128
Contact: Bruno Vincenzi, MD    003906-22541 ext 1123    b.vincenzi@unicampus.it   
Principal Investigator: Bruno Vincenzi, MD         
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy, 10060
Contact: Giovanni Grignani, MD    0039-011-993 ext 3623    giovanni.grignani@ircc.it   
Principal Investigator: Giovanni Grignani, MD         
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
Contact: Alessandra Longhi, MD    +390516366 ext 199    alessandra.longhi@ior.it   
Principal Investigator: Alessandra Longhi, MD         
Fondazione IRCSS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Contact: Silvia Stacchiotti, MD    +39022390    silvia.stacchiotti@istitutotumori.mi.it   
Principal Investigator: Silvia Stacchiotti, MD         
Ospedale Giaccone
Palermo, Italy
Contact: Giuseppe Badalamenti, MD       giuseppe.badalamenti@unipa.it   
Principal Investigator: Giuseppe Badalamenti, MD         
Sponsors and Collaborators
Italian Sarcoma Group
PharmaMar
Investigators
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Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Publications:

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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT04305548    
Other Study ID Numbers: ISG-MCS
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chondrosarcoma
Chondrosarcoma, Mesenchymal
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents