Spots Global Cancer Trial Database for Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
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Trial Identification
Brief Title: Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)
Official Title: Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas
Study ID: NCT06114004
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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. In the Phase I part safety and toxicity of the combination will be assessed using a 3+3 design. The recommended dose for the Phase II will be determined. In the Phase II part there will be 2 different cohorts: Cohort 1: Leiomyosarcoma (LMS) Cohort 2: Malignant peripheral nerve sheath tumor (MPNST)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Universitario de Canarias, Tenerife, Canarias, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario de Donostia, Donostia, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, , Spain
Hospital Clinico Universitario Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Javier MD Martín Broto
Affiliation: Hospital Universitario Fundación Jiménez Díaz
Role: STUDY_DIRECTOR
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