Study of Selinexor and Gemcitabine for Patients with Advanced Soft-Tissue Sarcoma

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What is this study about?

This clinical trial is focused on studying treatments for a type of cancer known as advanced soft-tissue sarcoma. Specifically, it looks at two subtypes: leiomyosarcoma and malignant peripheral nerve sheath tumor. The trial will test a combination of two medications: selinexor, which is taken as a tablet, and gemcitabine, which is given through an infusion into a vein.

The purpose of the study is to find the best dose of these medications when used together and to see how effective they are in treating the cancer. The study is divided into two phases. In the first phase, researchers will determine the safest and most effective dose of the combination treatment. In the second phase, they will evaluate how well the treatment works by looking at how long patients live without the cancer getting worse over a period of six months.

Participants in the study will receive the combination of selinexor and gemcitabine. Some participants may receive a placebo instead of selinexor. The study will monitor the participants’ health and any side effects they experience. The overall goal is to improve the treatment options for people with advanced soft-tissue sarcoma by finding a combination of medications that can help control the disease more effectively.

1 enrollment

Upon joining the study, the patient will provide written consent to participate. This consent is necessary before any study-specific procedures begin.

A series of tests will be conducted to confirm eligibility, including imaging tests and laboratory evaluations. These tests ensure the patient meets the study’s criteria, such as having a specific type of soft-tissue sarcoma and adequate organ function.

2 treatment initiation

The treatment phase begins with the administration of two medications: selinexor and gemcitabine.

Selinexor is taken orally, while gemcitabine is given intravenously as a solution for infusion.

The goal of this phase is to determine the maximum tolerated dose or the recommended dose for the next phase of the study.

3 treatment continuation

The patient will continue to receive the combination of selinexor and gemcitabine over a series of cycles. Each cycle lasts 21 days.

During this period, the patient’s response to the treatment will be closely monitored through regular assessments, including physical examinations and laboratory tests.

4 evaluation of treatment efficacy

The effectiveness of the treatment will be evaluated by measuring the progression-free survival rate at 6 months. This measures the percentage of patients who have not experienced disease progression or death within this timeframe.

Additional assessments will include overall response rate and tumor response according to specific criteria.

5 safety and quality of life assessment

Throughout the trial, the safety profile of the treatment will be assessed by monitoring any adverse events, their severity, and potential causes.

The patient’s quality of life will also be evaluated using a standardized questionnaire to understand the impact of the treatment on daily living.

6 follow-up

After completing the treatment phase, the patient will enter a follow-up stage. This involves regular check-ups to monitor long-term outcomes and any post-treatment effects.

The overall survival rate will be tracked, defined as the time from the first dose to any cause of death.

Who Can Join the Study?

Patients must provide written informed consent before any study-specific procedures and agree to follow treatment and follow-up plans.
Patients must have a left ventricular ejection fraction of 50% or higher. This is a measure of how well the heart pumps blood.
Females who can have children must have a negative pregnancy test within 72 hours before joining the study and agree to use birth control during the study and for 3 months after. Patients must not be pregnant or nursing when starting the study. Both women and men who can have children must agree to use effective birth control.
Patients must be between 18 and 80 years old.
Patients must have a confirmed diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) with a tumor sample provided for analysis.
Patients must have metastatic or advanced disease that has progressed in the last 6 months. Metastatic means the cancer has spread to other parts of the body.
Patients must have received at least one previous treatment for their condition.
Patients must have measurable disease according to RECIST 1.1 criteria, which is a standard way to measure how tumors respond to treatment.
Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, which indicates they are fully active or have some symptoms but can still carry out light work.
Patients must have adequate liver, kidney, heart, and blood function.
Laboratory tests must show:
- Absolute neutrophil count of 1,500/mm³ or higher. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count of 100,000/mm³ or higher. Platelets help with blood clotting.
- Bilirubin level of 1.5 mg/dL or lower. Bilirubin is a substance made by the liver.
- AST and ALT levels of 2.5 times the upper limit of normal or lower. These are liver enzymes.
- Creatinine level of 1.5 mg/dL or lower. Creatinine is a waste product filtered by the kidneys.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied, which are leiomyosarcoma (a type of cancer that affects smooth muscle tissue) or malignant peripheral nerve sheath tumor (a cancer that affects the protective lining of the nerves).
Patients who are not within the age range specified for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients who have allergies or reactions to the study medications or similar drugs.
Patients who have not recovered from side effects of previous treatments.
Patients who have certain infections or diseases that could affect their participation in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Hpzchony Ulcidanbhyfvs Dllcicld	Donostia / San Sebastian	Spain
Hxlayrwj Dx La Shpxf Cbja I Sqfd Pgd	Barcelona	Spain
Fxhqqdjzp Pihm Le Iozverozncxkb Bbeycoqwv Drf Hjpizijb Ueloaysrdquyo Lc Puj	Madrid	Spain
Hdwubwrw Vhxl dmsegzwy	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	02.11.2020

Trial locations

Investigated drugs:

Selinexor is a medication being studied for its potential to treat advanced soft-tissue sarcomas. It works by blocking a protein that helps cancer cells grow and spread. In this trial, researchers are trying to find the best dose of selinexor to use in combination with another drug.

Gemcitabine is a chemotherapy drug that is commonly used to treat various types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, gemcitabine is being used alongside selinexor to see if the combination is more effective in treating advanced soft-tissue sarcomas.

Investigated diseases:

Soft tissue sarcoma

Leiomyosarcoma – Leiomyosarcoma is a type of soft tissue sarcoma that originates in smooth muscle cells, which are found in involuntary muscles such as those in the uterus, stomach, and blood vessels. It typically presents as a firm, painless mass that can grow in size over time. As the tumor enlarges, it may press on surrounding tissues and organs, potentially causing discomfort or functional impairment. The disease can occur in various parts of the body, but it is most commonly found in the abdomen and uterus. Leiomyosarcoma is known for its potential to spread to other parts of the body, particularly the lungs and liver.

Malignant Peripheral Nerve Sheath Tumor – Malignant Peripheral Nerve Sheath Tumor (MPNST) is a rare type of cancer that develops in the protective lining of the nerves that extend from the spinal cord into the body. These tumors can arise spontaneously or in association with genetic conditions like neurofibromatosis type 1. MPNSTs often present as rapidly growing masses that may cause pain or neurological symptoms due to nerve compression. They can occur anywhere in the body but are most frequently found in the arms, legs, and trunk. The tumors are aggressive and have a tendency to invade surrounding tissues and metastasize to distant sites.

Trial ID:

2024-514827-40-00

Protocol code:

SELNET-7-1(SeliSarc)

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Selinexor and Gemcitabine for Patients with Advanced Soft-Tissue Sarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?