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OncoMatch/Clinical Trials/NCT06114004

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)

Is NCT06114004 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Selinexor 20 MG and Gemcitabine for sarcoma,soft tissue.

Phase 2RecruitingAsociación Europea y Latinoamericana SELNET para la Investigación en SarcomasNCT06114004Data as of May 2026

Treatment: Selinexor 20 MG · GemcitabinePhase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial. Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) 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

Must have received: systemic therapy — advanced disease

Patients have previously received at least one previous line of systemic therapy.

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.

Cannot have received: systemic therapy

Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).

Cannot have received: anti-cancer therapy or investigational product

Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1,500/mm³; Platelet count ≥ 100,000/mm³; Hgb not specified

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

Adequate hepatic, renal, cardiac, and hematologic function. Laboratory tests as follows: Absolute neutrophil count ≥ 1,500/mm³; Platelet count ≥ 100,000/mm³; Bilirubin ≤ 1.5 mg/dL; AST and ALT ≤ 2.5 times upper limit of normal; Creatinine ≤ 1.5 mg/dL. 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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