Actively Recruiting
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma
Led by Grupo Espanol de Investigacion en Sarcomas · Updated on 2024-01-23
14
Participants Needed
6
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and willingness to comply with study procedures
- Age between 18 and 80 years
- Histologically confirmed soft tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft-part sarcoma) or osteosarcoma
- Metastatic or advanced disease progressing in the last 6 months
- At least one previous systemic therapy received
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Adequate liver, kidney, heart, and blood function as defined by specified laboratory values
- Left ventricular ejection fraction of 50% or higher
- Negative pregnancy test for females of childbearing potential and agreement to use birth control during and 3 months after treatment
You will not qualify if you...
- Three or more prior lines of chemotherapy
- Prior treatment with selinexor or any other XPO1 inhibitor
- Previous treatment containing gemcitabine
- Any uncontrolled or active medical condition interfering with study procedures
- Active infection requiring intravenous antibiotics, antivirals, or antifungals within 1 week before treatment start
- Pregnant or breastfeeding females
- Body surface area less than 1.4 m2
- Life expectancy less than 3 months
- Major surgery within 4 weeks before treatment start
- Active gastrointestinal problems preventing swallowing or absorption of tablets
- Inability or unwillingness to take recommended supportive medications for nausea or anorexia
- Serious psychiatric or medical conditions that could interfere with treatment or consent
- Presence of brain or central nervous system metastases unless stable and treated
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Active, Not Recruiting
2
HU Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
3
H. Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
4
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
5
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
6
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
Research Team
P
Patricio Ledesma
CONTACT
G
Gabriel Joan Viver Llompart
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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