Actively Recruiting
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
Led by Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas · Updated on 2025-06-25
88
Participants Needed
11
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and agree to comply with treatment and follow-up
- Aged between 18 and 80 years
- Confirmed diagnosis of leiomyosarcoma or malignant peripheral nerve sheath tumor by central pathology
- Metastatic or advanced disease with progression in the last 6 months
- Have received at least one previous line of systemic therapy
- Measurable disease according to RECIST 1.1 criteria
- ECOG Performance Status of 0 or 1
- Adequate liver, kidney, heart, and blood function
- Laboratory values: neutrophils �01,500/mm3, platelets ��01,00,000/mm3, bilirubin ��01.5 mg/dL, AST and ALT ��02.5 times upper normal limit, creatinine ��01.5 mg/dL
- Left ventricular ejection fraction ��01 50% by echocardiogram or MUGA scan
- Females of childbearing potential must have a negative pregnancy test within 72 hours before enrollment and agree to use birth control during and for 3 months after treatment
- Patients must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential
You will not qualify if you...
- Have had three or more systemic treatment lines for advanced disease
- Received any other anti-cancer therapy or investigational product in the last 21 days
- Previous malignancy treated or recurrent within 5 years, except certain skin, cervical, or bladder cancers
- Prior treatment with selinexor or another XPO1 inhibitor
- Previous treatment with gemcitabine-containing regimens
- Any concurrent medical condition likely to interfere with study procedures
- Uncontrolled active infection needing parenteral antibiotics, antivirals, or antifungals within 1 week prior to cycle 1 day 1
- Pregnant or breastfeeding females
- Body surface area less than 1.4 m2 at baseline
- Life expectancy under 3 months
- Major surgery within 4 weeks prior to cycle 1 day 1
- Active gastrointestinal problems that interfere with swallowing or absorption of tablets
- Inability or unwillingness to take recommended supportive medications for nausea and anorexia
- Active serious psychiatric, medical, or other conditions that could interfere with treatment or consent
- Presence of brain or central nervous system metastases unless controlled and stable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain, 38320
Not Yet Recruiting
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
3
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
4
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain, 20014
Not Yet Recruiting
5
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28009
Not Yet Recruiting
6
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
7
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
8
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
9
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Not Yet Recruiting
10
Hospital Clinico Universitario Valencia
Valencia, Spain, 46010
Not Yet Recruiting
11
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
Research Team
P
Patricio Ledesma
CONTACT
I
Inés Torrens
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here