Study on Berzosertib and Gemcitabine for Adults with Advanced or Metastatic Soft-Tissue Leiomyosarcomas

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What is this study about?

This clinical trial is focused on studying a type of cancer known as soft-tissue sarcoma, specifically a subtype called leiomyosarcoma. Leiomyosarcoma is a cancer that arises from smooth muscle tissue, which can be found in various parts of the body. The study is investigating the effects of two treatments: Gemcitabine and Berzosertib (M6620). Gemcitabine is a chemotherapy drug that is commonly used to treat various types of cancer, while Berzosertib is an experimental drug that targets a specific protein involved in cancer cell repair and growth.

The purpose of this study is to evaluate how well Berzosertib works in combination with Gemcitabine in treating patients with advanced or metastatic leiomyosarcoma. The study will compare the effectiveness of the combination treatment to Gemcitabine alone. Participants in the study will receive either the combination of Berzosertib and Gemcitabine or Gemcitabine by itself. The study will monitor the participants over a period to see how the cancer responds to the treatments, specifically looking at whether the cancer shrinks, remains stable, or progresses.

Throughout the study, participants will receive their treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study aims to determine the safety and effectiveness of the treatments, as well as to gather information on any side effects experienced by the participants. The results of this study could provide valuable insights into new treatment options for patients with leiomyosarcoma.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent will be obtained to ensure understanding and agreement to participate.

Eligibility will be confirmed based on specific criteria, including a confirmed diagnosis of leiomyosarcoma and adequate organ function.

2 treatment assignment

The patient will be randomly assigned to one of two treatment groups: one receiving gemcitabine alone or the other receiving a combination of gemcitabine and berzosertib.

3 treatment administration

For those receiving gemcitabine alone, the medication will be administered as an intravenous infusion. The dosage and frequency will be determined by the study protocol.

For those receiving the combination treatment, both gemcitabine and berzosertib will be administered intravenously. The specific dosage and schedule will be outlined in the study protocol.

4 monitoring and assessments

Regular monitoring will occur to assess the patient’s response to treatment. This includes imaging studies to evaluate tumor size and progression.

Blood tests and other assessments will be conducted to monitor the patient’s health and any potential side effects.

5 follow-up

After completing the treatment phase, follow-up visits will be scheduled to continue monitoring the patient’s health and any long-term effects of the treatment.

The study aims to evaluate the effectiveness of the treatments over a period of time, with specific endpoints such as progression-free survival and overall survival being assessed.

Who Can Join the Study?

Must be an adult patient with advanced or not removable soft-tissue leiomyosarcomas.
Diagnosis of leiomyosarcomas must be confirmed by a specific network of experts.
Must agree to provide tumor samples for study purposes.
At least three weeks should have passed since the last cancer treatment like chemotherapy or radiotherapy.
Must have good blood, kidney, liver, and metabolic function. This includes specific levels of blood cells, liver enzymes, and kidney function.
Women who can have children must have a negative pregnancy test before starting the study.
Both men and women must use effective birth control methods during the study and for a period after the study ends.
No other cancer diagnosis or treatment in the last 2 years, except for certain types of skin or cervical cancer that were treated properly.
Must have recovered from any side effects of previous treatments, except for hair loss or mild nerve issues.
Must sign a consent form agreeing to participate in the study.
Must have health insurance as required by French law.
Must have advanced cancer that cannot be removed by surgery.
Must show cancer progression according to specific criteria, unless no prior treatment was received for advanced disease.
Must be 18 years or older.
Must have a good general health status, as measured by a specific scale.
Must have a life expectancy of more than 3 months.
No more than three previous treatments for advanced disease.
Must not be eligible for other treatments that are known to be beneficial.
Must have measurable disease, meaning the cancer can be measured in size using scans.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have had another cancer treatment recently that might interfere with the study.
Patients with serious health problems that could make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures for any reason.
Patients who have allergies to the study medications.
Patients who have participated in another clinical trial recently.
Patients with certain infections that could affect the study results.
Patients who have had a major surgery recently.
Patients with a history of certain heart problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Cqwekm Levm Bhysoe	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	09.02.2022

Trial locations

Investigated drugs:

Berzosertib is a medication being studied for its potential to help treat certain types of cancer, specifically soft-tissue sarcomas. It works by targeting a specific protein involved in the repair of damaged DNA in cancer cells, which may help to stop the growth of these cells.

Gemcitabine is a chemotherapy drug 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, it is used in combination with berzosertib to evaluate their combined effect on advanced or metastatic leiomyosarcomas.

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 considered a soft tissue sarcoma and can occur in any part of the body, but it most commonly affects the abdomen or limbs. The disease is characterized by the formation of malignant tumors that can grow and spread to other parts of the body. As it progresses, leiomyosarcoma may invade nearby tissues and organs, leading to various symptoms depending on the location of the tumor. The progression of the disease can vary significantly among individuals, with some experiencing slow growth and others facing rapid advancement.

Trial ID:

2023-509499-41-00

Protocol code:

IB 2018-04

NCT ID:

NCT04807816

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Berzosertib and Gemcitabine for Adults with Advanced or Metastatic Soft-Tissue Leiomyosarcomas

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