Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

NCT04535271 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SOC-2101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

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

  12 months

Secondary Outcomes (2)

• Overall Response

  6 weeks

• Adverse Event

  12 months

Study Arms (1)

Single arm

EXPERIMENTAL

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

Interventions

Trabectedin DRUG

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

Also known as: Gemcitabine, Dacarbazine

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarcoma Oncology Research Center, LLC: lead

Study Sites (1)

Sant P Chawla

Santa Monica, California, 90403, United States

RECRUITING

Related Publications (2)

• Maiti R. Metronomic chemotherapy. J Pharmacol Pharmacother. 2014 Jul;5(3):186-92. doi: 10.4103/0976-500X.136098.

  PMID: 25210398 BACKGROUND

• www.accessdata.fda.gov/drugsatfda_docs (Trabectedin, Gemcitabine, Dacarbazine)

  BACKGROUND

MeSH Terms

Conditions

Leiomyosarcoma

Interventions

Trabectedin; Gemcitabine; Dacarbazine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Triazenes; Organic Chemicals; Imidazoles; Azoles

Study Officials

• Sant P Chawla, MD

  Sarcoma Oncology Research Center, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sant P Chawla, MD

CONTACT

3105529999; santchawla@sarcomaoncology.com

Victoria Chua-Alcala, MD

CONTACT

3105529999; vchua@sarcomaoncology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: September 9, 2021
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)