OncoMatch/Clinical Trials/NCT04535271

Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

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

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

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

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Trabectedin

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 →

Frequently asked questions

Is NCT04535271 currently recruiting?

Yes, this trial is currently recruiting patients.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Sarcoma trials