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Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Leiomyosarcoma (TAGGED)

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: NCT04535271
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Sarcoma Oncology Research Center, LLC

Study Description
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Brief Summary:
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.

Condition or disease Intervention/treatment Phase
Leiomyosarcoma Drug: Trabectedin Phase 2

Detailed Description:

This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.

A total of 80 patients will receive trabectedin 0.5 mg/m2 as 24 hour continuous intravenous infusion (CIV) on D1 and D8, gemcitabine 250 mg/m2 i.v. on D1 and D8, and dacarbazine 250 mg/m2 i.v. on D1 and D8 (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan/MRI will be replaced.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Leiomyosarcoma
Actual Study Start Date : September 9, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
Trabectedin 24 h CIV 0.5 mg/m2 D1 and D8 Gemcitabine i.v. 250 mg/m2 D1 and D8 Dacarbazine i.v. 250 mg/m2 D1 and D8
 Drug: Trabectedin
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Other Names:
  • Gemcitabine
  • Dacarbazine


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 months ]
    Progression free survival up to disease progression or death from any cause


Secondary Outcome Measures :
  1. Overall Response [ Time Frame: 6 weeks ]
    Best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI

  2. Adverse Event [ Time Frame: 12 months ]
    Incidence of treatment-related adverse events


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female ≥ 18 years of age
  • Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma
  • Previously treated patient with measurable disease by RECIST v1.1
  • ECOG performance status ≤ 2
  • Life expectancy of at least 3 months
  • Acceptable liver function: Bilirubin < 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level < 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos < 2.5 x ULN (< 5 x ULN if liver metastases present)
  • Acceptable renal function: Creatinine < 1.5 times ULN and creatinine clearance > 60 ml/min using the Crockroft-Gault formula
  • Acceptable hematologic status: ANC >1000 cells/μL; Platelet count >100,000/μL; Hemoglobin > 9.0 g/dL
  • INR and PT < 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants
  • Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee
  • Willingness to comply with all study procedures and availability for the duration of the study
  • All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.

Exclusion Criteria:

  • Currently receiving treatment with another investigational device or drug study, or <14 days since ending treatment with another investigational device or drug study(s).
  • Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.
  • Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.
  • Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.
  • Sexually active subjects and their partners unwilling to use male or female latex condom
Contacts and Locations
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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): NCT04535271


Contacts
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Contact: Sant P Chawla, MD 3105529999 santchawla@sarcomaoncology.com
Contact: Victoria Chua-Alcala, MD 3105529999 vchua@sarcomaoncology.com

Locations
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United States, California
Sant P Chawla Recruiting
Santa Monica, California, United States, 90403
Contact: Sant P Chawla, MD    310-552-9999    santchawla@sarcomaoncology.com   
Contact: Victoria Chua-Alcala, MD    3105529999    vchua@sarcomaoncology.com   
Sponsors and Collaborators
Sarcoma Oncology Research Center, LLC
Investigators
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Principal Investigator: Sant P Chawla, MD Sarcoma Oncology Research Center, LLC
More Information
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Publications:
www.accessdata.fda.gov/drugsatfda_docs (Trabectedin, Gemcitabine, Dacarbazine)

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Responsible Party: Sarcoma Oncology Research Center, LLC
ClinicalTrials.gov Identifier: NCT04535271    
Other Study ID Numbers: SOC-2101
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Gemcitabine
Dacarbazine
Trabectedin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents