Recruiting
Phase 2

Trabectedin, Gemcitabine, Dacarbazine

Sponsor:

Sarcoma Oncology Research Center, LLC

Code:

NCT04535271

Conditions

Leiomyosarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trabectedin

Study Details

Brief summary:

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

Conditions

Leiomyosarcoma

Study ID

NCT04535271

Start date

Sep 9, 2021

Status verified date

Feb, 2025

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Trabectedin

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

Primary outcome measure

  • Progression free survival [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sant P Chawla, MD

3105529999santchawla@sarcomaoncology.com

Victoria Chua-Alcala, MD

3105529999vchua@sarcomaoncology.com

Locations

Sant P Chawla

Recruiting

Santa Monica, California, United States, 90403

Contacts

Sant P Chawla, MD

310-552-9999santchawla@sarcomaoncology.com

Victoria Chua-Alcala, MD

3105529999vchua@sarcomaoncology.com

More Information

Sponsor

Sarcoma Oncology Research Center, LLC

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sarcoma Oncology Research Center, LLC on 2025-02-24.