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OncoMatch/Clinical Trials/NCT06114004

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

Is NCT06114004 recruiting? Yes, currently enrolling (Jun 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 Jun 2026Location: Spain

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

Treatments studied

Chemotherapy

Gemcitabine

Other

Selinexor 20 MG

Cancer type

Sarcoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 80

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.

Frequently asked questions

Is NCT06114004 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior XPO1 inhibitor, gemcitabine-containing treatment, systemic therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger.

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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Related pages

Sarcoma trials