Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study Comparing Avutometinib and Defactinib with Other Treatments for Patients with Recurrent Low-Grade Serous Ovarian Cancer

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 ovarian cancer known as Recurrent Low-Grade Serous Ovarian Cancer (LGSOC). The study will explore the effects of a combination treatment using two medications, Avutometinib and Defactinib, compared to other treatments chosen by doctors. The goal is to see how well these treatments work in preventing the cancer from getting worse.

Participants in the study will receive either the combination of Avutometinib and Defactinib or one of the other treatments, which may include medications like pegylated liposomal doxorubicin, paclitaxel, topotecan, letrozole, or anastrozole. These treatments are commonly used for this type of cancer. The study will involve regular visits to the clinic for treatment and monitoring over a period of time.

The purpose of this study is to compare the effectiveness of the combination treatment with the other available options. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatments affect the cancer. This research aims to provide valuable insights into better treatment options for patients with Recurrent Low-Grade Serous Ovarian Cancer.

The research process

The trial runs in 4 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 randomly assigned to one of two groups: one receiving the combination therapy of avutometinib and defactinib, and the other receiving a treatment chosen by the investigator from a list of approved options.

  2. Step 2

    Treatment administration

    If assigned to the combination therapy group, the patient will take avutometinib and defactinib orally. The specific dosage and frequency will be determined by the study protocol.

    If assigned to the investigator's choice group, the patient may receive one of the following treatments: pegylated liposomal doxorubicin (infusion), paclitaxel (infusion), topotecan (infusion), letrozole (oral tablet), or anastrozole (oral tablet). The dosage and frequency will depend on the specific medication and the patient's medical history.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular visits for physical examinations, blood tests, and imaging studies to assess the progression of the disease.

    The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse.

  4. Step 4

    End of treatment

    The treatment will continue until the disease progresses, unacceptable side effects occur, or the patient decides to withdraw from the study.

    After the treatment ends, follow-up visits may be scheduled to monitor the patient's health and gather additional data on overall survival and other outcomes.

Who can join the trial?

13 criteria

  • Must be at least 18 years old.
  • Must have recovered from any side effects of previous treatments, except for hair loss or low thyroid function.
  • If able to have children, must have a negative pregnancy test before starting the study.
  • If able to have children, must agree to use a reliable form of birth control during the study and for 30 days after the last treatment.
  • Must be willing to attend all scheduled visits, follow the treatment plan, and complete all tests and procedures required by the study.
  • Must have a confirmed diagnosis of **Low-Grade Serous Ovarian Cancer (LGSOC)**, which can include cancer in the ovaries, fallopian tubes, or the lining of the abdomen.
  • Must be suitable for treatment with at least one of the following: pegylated liposomal doxorubicin, paclitaxel, topotecan, letrozole, or anastrozole, based on medical history and previous treatments.
  • Must have experienced a return or worsening of LGSOC after at least one round of platinum-based chemotherapy.
  • Must have normal organ function, as shown by specific blood tests and other health checks.
  • Must have a normal heart rhythm, with a QTc interval of 460 milliseconds or less, unless there is a specific heart condition.
  • Must have a documented **KRAS** gene status, which is determined by a specific test on tumor tissue.
  • Must have at least one tumor that can be measured according to specific guidelines.
  • Must have a performance status of 0 or 1 on the **Eastern Cooperative Oncology Group (ECOG)** scale, which measures daily living abilities.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) cannot participate.
  • Only female patients are eligible; male patients cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Avutometinib

    is a medication being studied for its potential to treat recurrent low-grade serous ovarian cancer. It is used in combination with another drug to see if it can help stop the cancer from growing or spreading.

  • Defactinib

    is another medication used in this study alongside avutometinib. It is being tested to determine if it can enhance the effectiveness of the treatment for patients with recurrent low-grade serous ovarian cancer.

What is already known about the treatment

  • Avutometinib

    Avutometinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating recurrent low-grade serous ovarian cancer (LGSOC). It is not yet widely used in standard medical practice, as it is still under investigation. The medication works by inhibiting specific proteins involved in cell growth and survival, which may help slow down or stop the progression of cancer. Avutometinib is classified as a targeted therapy, focusing on molecular pathways that are crucial for cancer cell proliferation.

  • Defactinib

    Defactinib is taken orally and is being evaluated in clinical trials for its potential to treat recurrent low-grade serous ovarian cancer (LGSOC). It is not yet approved for general medical use, as research is ongoing. The drug functions by blocking certain enzymes that contribute to cancer cell growth and spread, potentially reducing tumor progression. Defactinib is categorized as a targeted therapy, aiming to disrupt specific molecular mechanisms that cancer cells rely on for survival and growth.

Investigated diseases

Recurrent Low-Grade Serous Ovarian Cancer – This is a type of ovarian cancer characterized by the recurrence of cancerous cells in the ovaries, which are of a low-grade serous type. It typically grows slowly and is less aggressive compared to high-grade serous ovarian cancer. The disease often presents with symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. Over time, the cancer may spread to nearby tissues and organs within the pelvic region. The progression of this cancer can vary, with periods of stability followed by potential growth or spread. It is important to monitor the disease regularly to assess its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508204-38-00Protocol codeVS-6766-301Estimated enrolment308 patientsSponsorVerastem Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.