Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antimetabolites

Selinexor will be given at 60 mg once per week orally days 1, 8 and 15 every 21 days

Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days

After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor

Selinexor 20 MG

Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days.

Patricio Ledesma

Inés Torrens

Josefina MD Cruz

Ana MD Sebio

Claudia MD Valverde

Ana MD Paisán

Rosa MD Álvarez

Antonio MD Casado

Javier MD Martín Broto

Nadia Hindi

Andrés MD Redondo

Jerónimo MD Martínez

Alejandro MD Pérez Fidalgo

Javier MD Martínez Trufero

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 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)

each cohort (1 and 2) receives the same treatment.

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

Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas

To evaluate the efficacy of the selinexor plus gemcitabine combination as measured by the progression-free survival rate (PFSR) at 6 months in patients with selected advanced soft-tissue sarcomas.

Overall survival (OS): OS is defined as the time between the date of first dose and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.

Overall Response Rate (ORR): ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects.

Efficacy measured through tumor response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.

Safety profile of the experimental treatment, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests. Toxicity will be graded and tabulated by using CTCAE 5.0.

Quality of life will be measured with European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire 30

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)	NCT06114004	Sarcoma,Soft Ti...	Selinexor 20 MG Gemcitabine	18 Years - 80 Years	Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)	NCT06114004	Sarcoma,Soft Ti...	Selinexor 20 MG Gemcitabine	18 Years - 80 Years	Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)	NCT06114004	Sarcoma,Soft Ti...	Selinexor 20 MG Gemcitabine	18 Years - 80 Years	Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas

Spots Global Cancer Trial Database for selinexor 20 mg