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 advanced soft-tissue sarcomas, specifically leiomyosarcoma and malignant peripheral nerve sheath tumor. The trial will test a combination of two treatments: 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 and to see how effective they are in treating these types of cancer.

The study will be conducted in two phases. In the first phase, the goal is to determine the safest and most effective dose of the combination of selinexor and gemcitabine. In the second phase, the study will evaluate how well this combination works in preventing the cancer from getting worse over a period of six months. Participants will receive the treatment and be monitored regularly to assess their response to the medication and any side effects they may experience.

Throughout the study, participants will undergo various assessments to monitor their health and the progress of their cancer. These assessments will include regular check-ups and tests to ensure the treatment is working as intended and to manage any potential side effects. The study aims to provide valuable information on the effectiveness and safety of using selinexor and gemcitabine together for treating advanced soft-tissue sarcomas.

1 initial treatment phase

The trial begins with the administration of two medications: selinexor and gemcitabine. Selinexor is taken orally, while gemcitabine is given through an intravenous infusion.

The purpose of this phase is to determine the maximum dose that can be tolerated or the recommended dose for the next phase of the trial.

2 dose determination

During this phase, the focus is on observing any side effects that occur during the first cycle of treatment, which lasts from day 1 to day 21.

The information gathered will help in deciding the appropriate dosage for the subsequent phase.

3 efficacy evaluation

The next phase involves assessing the effectiveness of the treatment combination. This is measured by the rate of patients who do not experience disease progression or death within six months of starting the treatment.

The evaluation is based on specific criteria that track changes in the size of the tumor.

4 safety and quality of life assessment

Throughout the trial, the safety of the treatment is monitored by recording any adverse effects, their severity, and timing.

Quality of life is also assessed using a standardized questionnaire to understand the impact of the treatment on daily living.

5 follow-up and overall survival

The final phase involves long-term follow-up to observe overall survival, which is the time from the first dose until death from any cause.

This phase also includes monitoring any treatments received after the trial and their outcomes.

Who Can Join the Study?

Patients must provide written informed consent before any study-specific procedures and agree to follow the treatment and follow-up plan.
Patients must have a left ventricular ejection fraction of 50% or higher. This is a measure of how well the heart is pumping 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 breastfeeding 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 worsened 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 well a cancer treatment is working.
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 do not need to stay in bed.
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 do not have advanced soft-tissue sarcoma, such as leiomyosarcoma (a type of cancer that starts in smooth muscle tissue) or malignant peripheral nerve sheath tumor (a cancer that forms in the protective lining of the nerves).
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

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
Hzyntqmo Vdgo dblzgjbe	Barcelona	Spain
Hwqoylxl Uyekkbrpraeih Dtexatxm	Donostia / San Sebastian	Spain
Hcaolsyb De Ln Sqbza Czmq I Srvs Pmk	Barcelona	Spain
Fmpgkiddz Polp Lj Ipjmtdrcbstzk Bniclgauj Dmj Hvlaekuf Unqaxknjordlv La Pww	Madrid	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 certain types of cancer. 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 to treat advanced soft-tissue sarcomas.

Gemcitabine is a chemotherapy drug that is 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 cancer that originates in smooth muscle tissue, which is found in various parts of the body such as the uterus, stomach, and blood vessels. It is a rare and aggressive form of soft tissue sarcoma. The disease often presents as a painless mass, and as it progresses, it may cause discomfort or interfere with the function of nearby organs. Leiomyosarcoma can spread to other parts of the body, particularly the lungs and liver. The progression of the disease can vary significantly among individuals.

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. It is associated with genetic conditions like neurofibromatosis type 1. MPNSTs can grow rapidly and may cause pain, weakness, or loss of function in the affected area. As the tumor enlarges, it can invade surrounding tissues and potentially spread to other parts of the body. The progression of MPNST can be aggressive, requiring careful monitoring.

Trial ID:

2024-520318-23-00

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?