OncoMatch/Clinical Trials/NCT04595994

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma

Is NCT04595994 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Selinexor for sarcoma,soft tissue.

Phase 1RecruitingGrupo Espanol de Investigacion en SarcomasNCT04595994Data as of May 2026

Treatment: Selinexor — Phase I-II, randomized, open-label, multicenter, international clinical trial Patients with advanced soft-tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft-part sarcoma) and osteosarcoma will receive selinexor in combination with gemcitabine.

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Extracted eligibility criteria

Cancer type

Sarcoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Min 1 prior line

Cannot have received: XPO1 inhibitor (selinexor)

Prior selinexor or another XPO1 inhibitor treatment.

Cannot have received: gemcitabine-containing treatment (gemcitabine)

Administration of a previous gemcitabine-containing treatment.

Lab requirements

Blood counts

absolute neutrophil count ≥ 1,500/mm³; platelet count ≥ 100,000/mm³

Kidney function

creatinine ≤ 1.5 mg/dl

Liver function

bilirubin ≤ 1.5 mg/dl; ast and alt ≤ 2.5 times upper limit of normal

Cardiac function

left ventricular ejection fraction ≥ 50% by echocardiogram or muga scan

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

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