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Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma

NCT04595994 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-01-23

No results posted yet for this study

Summary

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

  • Sarcoma,Soft Tissue

Interventions

DRUG

Selinexor

For both interventional ( Selinexor and Gencitabine) Dose-limiting toxicity (DLT) will be applied only to either of the following toxicities occurring during the first treatment cycle (days 1-21).

Sponsors & Collaborators

  • Grupo Espanol de Investigacion en Sarcomas

    lead OTHER

Principal Investigators

  • Javier Martín Broto, MD · Hospital Fundación Jiménez Díaz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2025-11-30
Completion
2026-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595994 on ClinicalTrials.gov