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

Primary Purpose

Leiomyosarcoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trabectedin
Sponsored by
Sarcoma Oncology Research Center, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sant P ChawlaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival
Progression free survival up to disease progression or death from any cause

Secondary Outcome Measures

Overall Response
Best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI
Adverse Event
Incidence of treatment-related adverse events

Full Information

First Posted
August 27, 2020
Last Updated
October 13, 2022
Sponsor
Sarcoma Oncology Research Center, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04535271
Brief Title
Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Leiomyosarcoma
Acronym
TAGGED
Official Title
TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Leiomyosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sarcoma Oncology Research Center, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Other Intervention Name(s)
Gemcitabine, Dacarbazine
Intervention Description
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
Primary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival up to disease progression or death from any cause
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Response
Description
Best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI
Time Frame
6 weeks
Title
Adverse Event
Description
Incidence of treatment-related adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sant P Chawla, MD
Phone
3105529999
Email
santchawla@sarcomaoncology.com
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Chua-Alcala, MD
Phone
3105529999
Email
vchua@sarcomaoncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sant P Chawla, MD
Organizational Affiliation
Sarcoma Oncology Research Center, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sant P Chawla
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sant P Chawla, MD
Phone
310-552-9999
Email
santchawla@sarcomaoncology.com
First Name & Middle Initial & Last Name & Degree
Victoria Chua-Alcala, MD
Phone
3105529999
Email
vchua@sarcomaoncology.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25210398
Citation
Maiti R. Metronomic chemotherapy. J Pharmacol Pharmacother. 2014 Jul;5(3):186-92. doi: 10.4103/0976-500X.136098.
Results Reference
background
Citation
www.accessdata.fda.gov/drugsatfda_docs (Trabectedin, Gemcitabine, Dacarbazine)
Results Reference
background

Learn more about this trial

Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Leiomyosarcoma

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