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OncoMatch/Clinical Trials/NCT04535271

Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

Is NCT04535271 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trabectedin for leiomyosarcoma.

Phase 2RecruitingSarcoma Oncology Research Center, LLCNCT04535271Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Sarcoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Lab requirements

Blood counts

ANC >1000 cells/μL; Platelet count >100,000/μL; Hemoglobin > 9.0 g/dL

Kidney function

Creatinine < 1.5 x ULN and creatinine clearance > 60 ml/min using the Crockroft-Gault formula

Liver function

Bilirubin < 1.5 x ULN (except Gilbert Syndrome < 3.0 x ULN); AST, ALT, alk phos < 2.5 x ULN (< 5 x ULN if liver metastases present)

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Sant P Chawla · Santa Monica, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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