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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

19 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

Berzosertib – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic leiomyosarcomas, a type of soft-tissue cancer. It is not yet widely used in standard medical practice, as it is still under investigation. Berzosertib works by inhibiting a protein called ATR, which is involved in DNA repair processes, potentially leading to cancer cell death. It is classified as an ATR inhibitor and is being evaluated for its ability to improve progression-free survival in combination with another drug, gemcitabine.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509499-41-00Protocol codeIB 2018-04Estimated enrolment72 patientsSponsorInstitut Bergonie

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).