Recruiting

Open‑Label Extension Study of Avutometinib Alone or with Defactinib in Patients with Recurrent Low‑Grade Serous Ovarian Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

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

The study focuses on patients with recurrent Low-Grade Serous Ovarian Cancer, a type of ovarian cancer that can return after initial treatment. The medicines being given are an oral tablet called defactinib and an oral capsule called avutometinib, which may be taken alone or together.

The purpose is to keep providing these medicines to people who are still benefiting after finishing a previous trial. Participants will continue to take the assigned medicine(s) for a period of time, visiting the clinic periodically for check‑ups and lab tests to see how they are doing.

Doctors will look for any ongoing benefit, such as the cancer not growing, and will also record any side effects, including changes in blood work or physical exam findings. The study does not involve any additional experimental procedures beyond the regular medication schedule.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment in the extension study
After completing the previous study, you are offered continued access to the medication.
You sign an informed consent form that explains the purpose and procedures of the extension study.
Step 2
Baseline evaluation
The study team reviews your medical records and confirms that you have recurrent low‑grade serous ovarian cancer and are still benefiting from the previous treatment.
A physical examination, blood tests, and imaging studies are performed to establish a starting point for the extension study.
Step 3
Medication assignment
You are assigned to receive either avutometinib alone or a combination of avutometinib with defactinib based on the study protocol.
Step 4
Start of treatment
You begin taking the study medication by mouth each day.
If you receive defactinib, the dose is 400 mg per tablet taken once daily.
If you receive avutometinib, the dose is 3.2 mg per hard capsule taken once daily.
When both drugs are prescribed, each is taken once daily as described.
Step 5
Daily dosing
The tablets and capsules are swallowed with water.
The medication can be taken with or without food, unless your doctor advises otherwise.
You continue this daily schedule for the duration of the study.
Step 6
Regular clinic visits
You attend a study visit approximately every 4 weeks.
During each visit the team checks your health, reviews any side effects, and performs blood tests and other examinations.
Step 7
Laboratory monitoring
Blood samples are taken to monitor organ function and to detect any abnormal laboratory findings.
Results are compared with previous values to assess safety.
Step 8
Assessment of clinical benefit
The investigator evaluates whether the cancer continues to respond to the treatment.
This determination is the primary endpoint of the study.
Step 9
Side‑effect monitoring
You are asked to report any new symptoms, such as fatigue, nausea, or changes in lab results.
The frequency and severity of side effects are recorded as a secondary endpoint.
Step 10
Continuation or discontinuation of therapy
If the investigator judges that you are still receiving clinical benefit and side effects are manageable, you continue the daily medication.
Treatment may be stopped early if the cancer progresses or if side effects become unacceptable.
Step 11
Final evaluation and study closure
The study is planned to continue until the estimated end date of january 2028.
At the final visit a comprehensive assessment is performed, including imaging, laboratory tests, and a review of overall benefit and safety.

Who can join the trial?

6 criteria

You have finished the earlier RAMP‑201 study and were taking either the medicine avutometinib alone or together with defactinib, and you can move straight into this new study without a break.
You are currently getting a continued benefit from the previous treatment, meaning your cancer is either gone completely (complete response), has shrunk (partial response), or is not getting worse (stable disease) as judged by your doctor.
Any pause in taking the study medicine during the earlier trial was no longer than 28 days when you are screened for this study.
Your doctor believes that staying on the treatment is best for you and that you meet all the study’s specific rules for continued treatment; the study sponsor may also check this.
If you are a woman who could become pregnant, you must agree to use a highly effective method of contraception (birth control) during the study and for at least 30 days after your last dose, and you must have a negative pregnancy test (blood serum or urine) before starting.
You must be able and willing to sign a written informed consent form, agreeing to take part and allowing the study to collect your data.

Who cannot join the trial?

9 criteria

If scans (radiographic tests) or doctor examinations show that the cancer has gotten worse, or if treatment was stopped because side effects were too severe during the earlier study or at the time of this screening.
If your treatment was put on hold in the earlier study, you can join this study only after the problem that caused the hold is fully resolved and the doctor confirms it is safe to continue.
If you have started any new cancer medicine (systemic anti‑cancer therapy) since finishing the earlier study.
If you are currently taking part in another research trial (interventional clinical study) or have received any other experimental therapy since the earlier study.
If you have any serious or uncontrolled health condition that could be risky or interfere with the study treatment, such as severe heart, lung, nerve, skin, stomach, liver, or active infection problems.
If you have any current or past eye disorder (ocular disorder) that could increase the chance of eye problems from the study drugs, such as retinal vein blockage, swelling of the retina (serous retinopathy), retinal detachment, or significant macular disease.
If you are taking medicines that strongly interact with the study drugs and cannot be safely stopped or replaced, such as strong CYP3A4 enzyme inducers or inhibitors, or the blood thinner warfarin.
If you have a positive pregnancy test, are breastfeeding, or are unwilling to use reliable birth control (contraception) during the study.
If the doctor believes any other condition or situation could put your safety at risk, make it hard for you to follow the study rules, or reduce the benefit you might receive from the treatment.

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Verified sites

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Verified
Centre Leon Berard
Lyon, France
Verified
Institut Curie - Site Paris
Paris, France

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Investigated drugs

Defactinib
is an oral medication taken as a tablet. It belongs to a group of drugs that block certain signals inside cancer cells that help them grow and spread. In this study, defactinib is being given to patients with recurrent low‑grade serous ovarian cancer to see if it can keep the disease under control after earlier treatment.
Avutometinib
is an oral medication taken as a hard capsule. It works by inhibiting a protein that many cancer cells need to multiply. In this trial, patients receive avutometinib either by itself or together with defactinib to evaluate how well it continues to control the ovarian cancer that has come back.
Combination therapy of Avutometinib with Defactinib
involves giving both medications at the same time. The goal of using the two drugs together is to target the cancer through two different pathways, which may improve the chance of slowing or stopping tumor growth in patients who are still benefiting from treatment.

What is already known about the treatment

Defactinib
This drug is taken by mouth as a 400 mg tablet. It is still experimental and being studied in clinical trials, not yet approved for general medical use. Defactinib is being tested for recurrent low‑grade serous ovarian cancer and works by blocking a protein called focal adhesion kinase, which helps cancer cells grow and spread. It belongs to the class of tyrosine‑kinase inhibitors.
Avutometinib
This medication is taken orally in a hard capsule containing 3.2 mg. It is also an investigational drug currently in clinical studies and has not received regular market approval. Avutometinib is aimed at treating recurrent low‑grade serous ovarian cancer and acts by inhibiting MEK1/2 enzymes in the MAPK signaling pathway, slowing down cancer cell growth. It is classified as a MEK inhibitor.

Investigated diseases

Recurrent Low‑Grade Serous Ovarian Cancer (LGSOC) - Recurrent low‑grade serous ovarian cancer is a slowly growing cancer that starts in the lining of the ovary. After the first treatment, the disease can return, showing up again in the same area or elsewhere in the abdomen. The tumor cells usually keep a similar appearance to the original cancer and continue to grow at a modest rate. Over time, the disease may spread to nearby tissues or the lining of the abdomen, causing new growths. The pattern of return can be gradual, with symptoms developing slowly as the tumor enlarges. Monitoring is needed to see how the disease changes.