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New treatment option for Sarcoma,Soft Tissue
Official title Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
ClinicalTrials.gov ID: NCT06114004
What this study is testing
What is Selinexor 20 MG?
Selinexor 20 MG is an investigational medicine, being studied as a potential treatment for sarcoma,soft tissue.
Also referred to as KPT-330.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and...
- Age: 18-80 years.
- Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior...
- Metastatic/advanced disease in progression in the last 6 months.
- Patients have previously received at least one previous line of systemic therapy.
You likely can't join if
- Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).
- Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.
- Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical...
- Prior selinexor or another XPO1 inhibitor treatment.
- Administration of a previous gemcitabine-containing treatment.
- Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.)...
See the full eligibility criteria
- Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the...
- Age: 18-80 years.
- Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior to enrolment with an archive tumor sample. A fresh paraffin embedded...
- Metastatic/advanced disease in progression in the last 6 months.
- Patients have previously received at least one previous line of systemic therapy.
- Measurable disease according to RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- 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 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan. 11\. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to...
- Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).
- Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.
- Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 5 years prior...
- Prior selinexor or another XPO1 inhibitor treatment.
- Administration of a previous gemcitabine-containing treatment.
- Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week...
- Pregnant or breastfeeding females.
- Body surface area (BSA) \<1.4 m2 at baseline, calculated by the Du Bois(25) or Mosteller(26) method.
- Life expectancy of less than 3 months.
- Major surgery within 4 weeks prior to C1D1.
- Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.
- Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia/cachexia (palliative care).
- Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. 15. Presence of...
- Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)
The study team makes the final eligibility decision.
Where it's taking place
- Santa Cruz de Tenerife, Canary Islands, Spain
- Barcelona, Spain
- Donostia / San Sebastian, Spain
- Madrid, Spain
- Murcia, Spain
- Valencia, Spain
- Zaragoza, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Cruz de Tenerife, Canary Islands, Spain; Barcelona, Spain; Donostia / San Sebastian, Spain; Madrid, Spain; Murcia, Spain; Valencia, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.